CAROLYN KNIGHT BUPPERTATTORNEY AT LAW

1419 FOREST DRIVE, SUITE 2O5

ANNAPOLIS, MARYLAND 214O3

TELEPHONE (410)269-0912

Original: 2064June 26, 2000

Robert E. NyceExecutive DirectorIndependent Regulatory Review CommissionAttn: Regulation 16A-499333 Market St., 14th FloorHarrisburg, PA 17101

Re: Regulation 16A-499

Dear Mr. Nyce,

I am writing at the suggestion of John Jewett, whom I called last week at the request of Morgan

In my opinion, the requirement specified in Annex A, Sections 18.57(a) and 21.287(a) that "Aphysician shall not serve as the collaborative physician for more than two CRNPs who prescribeand dispense drugs at any one time" is more restrictive than any state in the nation.

Very few states limit the number of CRNPs with whom a physician may collaborate for thepurposes of prescribing or otherwise providing health care. None narrow the number to two. NewYork specifies four and Texas specifies three full time equivalents.

In eight states, CRNPs may prescribe without physician collaboration, supervision or direction.

My comments are based on my own research of the law of all states on nurse practitionerprescriptive authority. It did the research for my book "The Nurse Practitioner's Business Practiceand Legal Guide," published by Aspen Publishers in 1998.

In addition, please note that there are no data, from scientific studies or from malpractice cases, tosupport the language in the above-referenced sections.

Sincerely,

Carolyn Buppert

Sent by: CAPITAL ASSOCIATES 717 234 5350; 10/19/00 13:04; #385;

A C P

AS1M

American Collegeof Physicians

American Societyof Internal Medicine

Or ig ina l : 2064

PENNSYLVANIA CHAPTER

October 18,2000

Th* Honorable John R. McGintey, )r.ChairmanIndependent Regulatory Review Commission333 Market Street14th FloorHarrisburg. PA 17101

PENNSYLVANIA COLLEGE OF INTERNAL MEDICINE

i %.1

b

Dear Chairman McGinley;

Please accept these comments from the Pennsylvania College of Internal Medicine and its 6000 members inthe Commonwealth.

We feel compelled to voice our objection to the revised final rulcmakfag pertaining to prescriptive authorityfor CRNP's (16A-49a). The purpose of a "collaborative agreement" between an advanced practice nurseand a physician is to permit adequate oversight of the medical aspects of the care provided. We feel thaithere should be some limit on the number of nurses with whom a single MD can sign such an agreement.The "four at a time" scenario allows for the possibility that the physician may be responsible for moreCRKPs than he can adequately oversee. Oversight implies much more than being available at the time theservices are rendered. It's an ongoing commitment for as long as the patient remains under the care of thatpractitioner. On some level the collaborating MD must remain abreast of the care provided.

The remaining rules are acceptable.

Yours truly, fM Mttr

cc: The Honorable Clarence D. BellChair, Senate Consumer Protection & Professional Ucensure CommitteeSenate Box 203009Hwrhbui& PA 17120-3009

The Honorable Mario 1 Civera, Jr.Chair, House Professional Licensure CommitteeHouse Box 202020llaiTUbunk PA 17120-2020

Carol Rose, MDPresident, Pennsylvania Medical Society777 East Park DriveHanttburg,PA I 7105-8820

2OONORTH 3RD STREET, SUITE I402 • P,O, Box671 * HARRISBURG, PA 17108-O671017) 234-5351 • (800) 846 7746 • FAX <717) 234-2286 • EMAIL PCIM©CAPITALASSOC.COM

10/18/00 WED 20:03 FAX

SttIOriginal: 2064

October 18,2000

EMBARGOED MATERIAL

A slate organization oflong-term care physicianscommitted to quality cate

PennsylvaniaMedical Directors

Association

Margaret B. Kush, MD, CMDPittsburgh, 412-4864677

President-EledDaniel Halmowitz, MO, CMD

Levittown, 215-943-2222

Immediate Past PresidentMario|,Canacditone,DOfCMD

Wifces-Bane, 570-825-5892

Louis CDeMarta, MO, CMDPhiladelphia, 215-241*2846

Glenn M, Panzer, MD.CMDLuzeme, 570-287-3131

Board of DirectorsAndrew E.Hickey,MD,CMD

SefiR.Knofale.MD

DavidA.Nace,MD,MPH

MarkOverton,MD

MacHZisselman.MD

Inter Specialty SectionRepresentative to

Pa Medial SocietyMandellj.Much,DO,CMD

CoiKotdviile

Administrative Office777 East Park Drive

P.O. Box 8820Hairisburg, PA 17105-8620

Phone: 717-558-7868FAX: 717-558-7841

Executive DirectorOiariencM.Wandzi!ak

Official PennsylvaniaChapter of American Medical

Directors Association

RECE^^n

2#0CTI9 AM 7:43Mr. John R McGinley, Jr., Esq.Chairman, Independent Regulatory Review Commission ^ y ^ r _ •' ^ <vr°^ v333 Market Street, 14th FloorHanisburg, PA 17101

Dear Mr. McGinley:

I am writing as President of the Pennsylvania Medical Directors Association insupport of the proposed rulemaking pertaining to prescriptive authority forcertified nurse practitioners (CRNPs) with the amendments offered by the StateBoards of Medicine and Nursing. The Pennsylvania Medical DirectorsAssociation is a professional organization of over 250 medical directors andattending physicians involved in the continuum of long-term care.

We have reviewed and find acceptable the recommendations proposed by theState Boards and support the efforts of the State Board of Medicine and the StateBoard of Nursing to promulgate regulations which address nurse practitionerprescriptive authority and the process by which it may occur. It is our sincerehope that the Independent Regulatory Review Commission will approve theproposed rulemaking with the recommended changes. Thank you for yourconsideration. If you have any questions, please feel free to contact our office at(717)558-7868.

Sincerely yours,

0Margaret Kush, MD, CMDPresident

cc: The Honorable Clarence D. BellThe Honorable Mario J. Civera, Jr.

10 /18 /00 WED 20 :01 FAX «eiuu±

EMBARGOED MATERIAL

American College of SurgeonsEastern Pennsylvania Chapter

! • • -

o

Facsimile Cover Sheet

To: Mr. John McGinleyCompany: IRRC

Phone:Fax: 717-783-2664

From: Charles Scagliotti, MD,FACS

Company: ECACSPhone: 717-558-7750, ext. 1476

Fax: 717-558-7845

Date: 10/18/2000Pages including this 2

cover page:

Comments: Comments: PLEASE DELIVER BY 10:00 a.m. onTHURSDAY, OCTOBER 19.

Enclosed please find the PMDA's letter of support regarding theproposed rulemaking with amendments recommended by theState Boards of Medicine and Nursing in regards to theprescriptive authority of CRNPs. Thank you for yourconsideration.

10/18/00 WED 20:01 FAX

Original: 2064 SlMv EMBARGOED MATERIAL

EXECUTIVE COUNCIL 1999-2000

Chaths J. Scagtm M.D., FACS1210 & Cedar Cm* Boulevard

Atontom, PA 18103*6218(610) 770-3270

Pmddi+eteetRobert J. Stonott. DO., FACS706 Shady Retreat Road

Doyhstown, PA 18901-2503(215)348-4677

$9crwt*ryTnasun*Joseph L Qarberino, M.D., FACSP.O. Box 20847Ltbfgh VafeK. PA 18002-0847(610) 891-0973

Frederick C Bayer, III, M.D., FACSJohn V. LaMenna, MO., FACS

Ch*pfrr AdministratorChurkneWandzHakPennsytonlo Medical Socbty777 Bast Park DriveP.O. Box 8820Hamsburg, PA 17105-8820(888) 633-5784(717) 558-7750(FAX) 668-7841cwandzH0k@pamadsoG.orgwww.sasfpa8urgmons.org

^iSIIIS:|^y

October 18,2000

ii

2Mr. John R. McGinley, Jr., Esq.Chairman, Independent Regulatory Review Commission333 Market Street, 14th FloorHarrisburg, PA 17101

Dear Mr, McGinley:

I am writing as President of the Eastern PA Chapter of the American College ofSurgeons in support of the proposed rulemaking pertaining to prescriptiveauthority for certified nurse practitioners (CRNPs) with the amendments offeredby the State Boards of Medicine and Nursing. The Eastern PA Chapter of theAmerican College of Surgeons represents over 650 surgeons in theCommonwealth.

We have reviewed and find acceptable the recommendations proposed by theState Boards and support the efforts of the State Board of Medicine and the StateBoard of Nursing to promulgate regulations which address nurse practitionerprescriptive authority and the process by which it may occur. It is our sincerehope that the Independent Regulatory Review Commission will approve theproposed rulemaking with the recommended changes. Thank you for yourconsideration. If you have any questions, please feel free to contact our office at(717) 558-7750, ext. 1476.

20

a

Sincerely yours,

eufj^fatk<t*

Charles 3. Scagliotti, MD, FACSPresident

cc: The Honorable Clarence D. BellThe Honorable Mario J. Civera, Jr.

10/18 /00 WED 20:03 FAX igjuui

EMBARGOED MATERIAL

2000 OCT 19 &H7:i*3

R£Vi£w C o : - ; . - ; i i ^ 0 H ' '

Pennsylvania MedicalDirectors Association

Facsimile Cover Sheet

To: John McGinley, Jr., Esq.Company: IRRC

Fax: 717-783-2664

From: Margaret Kush, MD, CMDCompany: PMDA

Phone: 717-558-7868Fax: 717-558-7845

Date: 10/18/2000Pages including this 2

cover page:

Comments: PLEASE DELIVER BY 10:00 a.m. on THURSDAY,OCTOBER 19.

Enclosed please find the PMDA's letter of support regarding theproposed rulemaking with amendments recommended by theState Boards of Medicine and Nursing in regards to theprescriptive authority of CRNPs. Thank you for yourconsideration.

INDEPENDENT REGULATORYREVIEW COMMISSION

To: Suzanne HoyAgency: Department of State

Licensing Boards and CommissionsPhone 7-2628

Fax: 7-0251

From: Kristine M. ShomperDeputy Director for Administration

Company: independent Regulatory ReviewCommission

Phone: (717) 783-5419 or (717) 783-5417Fax: (717)783-2664

Date: October 19, 2000# of Pages: 5

Embargoed Mail Reed.

A C P

ASIM

American Collegeof Physicians

American Societyof Internal Medicine

RECEIVED

20DQCGT23 m frSflPENNSYLVANIA CHAPTER PENNSYLVANIA COLLEGE OF INTERNAL MEDICINE

-- -. t ^ *_ -r pj n y

October 18, 2000 Original: 2064REVI^; CUHniSblON

#

The Honorable John R. McGinley, Jr.ChairmanIndependent Regulatory Review Commission333 Market Street14th FloorHarrisburg, PA 17101

Dear Chairman McGinley:

Please accept these comments from the Pennsylvania College of Internal Medicine and its 6000 members inthe Commonwealth.

We feel compelled to voice our objection to the revised final rulemaking pertaining to prescriptive authorityfor CRNP's (16A-49a). The purpose of a "collaborative agreement" between an advanced practice nurseand a physician is to permit adequate oversight of the medical aspects of the care provided. We feel thatthere should be some limit on the number of nurses with whom a single MD can sign such an agreement.The "four at a time" scenario allows for the possibility that the physician may be responsible for moreCRNPs than he can adequately oversee. Oversight implies much more than being available at the time theservices are rendered. It's an ongoing commitment for as long as the patient remains under the care of thatpractitioner. On some level the collaborating MD must remain abreast of the care provided.

The remaining rules are acceptable.

Yours truly, VfrJP frkotr

RaipWSchmeltz, MD, FACP, FACPresident

cc: The Honorable Clarence D. BellChair, Senate Consumer Protection & Professional Licensure CommitteeSenate Box 203009Harrisburg, PA 17120-3009

The Honorable Mario J. Civera, Jr.Chair, House Professional Licensure CommitteeHouse Box 202020Harrisburg, PA 17120-2020

Carol Rose, MDPresident, Pennsylvania Medical Society777 East Park DriveHarrisburg, PA 17105-8820

200 NORTH 3RD STREET, SUITE 1402 • P.O. Box 671 • HARRISBURG, PA 17108 - 0671(717)234-5351 • (800)846-7746 • FAX (717) 234-2286 • EMAILPCIM@CAP1TALASSOC.COM

AmericanAcademy ofPediatrics

Pennsylvania ChapterRosemont Business CampusBuilding 2. Suiic 307919 Conestoga RoadRosemont. PA 19010610/520-9123 Fax 610/520-91771-XOO-33-PA AAPpaaapfc/ voiccnct.com

President

Mark S. Reuben, M.D.Reading Pediatrics40 Berkshire CourtWyomissing, PA 19610610/374-7400 Fax 610/374-1641

Vice President.1. Carlton Gartner. M.D.Children's Hospital of Pittsburgh3705 Fifth AvenuePittsburgh, PA 15213412 692-5135 Fax 412/692-7038

Secretary Treasurer

Robert Cicco. M.D.Western PA Hospital4800 Friendship AvenueSuite Ni-3420Pittsburgh. PA 15224412/57X-5S5S Fax 412/578-1529

Members At LargeF. Dennis Dawgert, M.D.Diekson City. PA

Barbara P. Homcicr. M.D.Sellcrsville. PA

Anthony A. Lubcrti. M.D.Philadelphia. PA

Allen S. Nussbaum, M.D.

Mary Ann Rigas. M.D.Coudersport. PA

Eva P. Vogelcy. M.DGibsonia. PA

Past PresidentBradley .1. Bradford M.D.Pittsburgh. PA

Executive DirectorSuzanne C Yunghans

Traffic Injury Prevention ProjectJcrold M. Aronson. M.D., M.P.H.

Early Childhood EducationLinkage SystemSusan S. Aronson. M.D.

Immunization Education Program

Alan \i. Kohrt, M.D.

Smoking Cessation Program

L-nglish D Willis, M.D.

Child Death Review Program

David Turkewitz. M.D.

Child Abuse Education Program

Cindy Christian. M.D.

October 17, 2000

John McGinley, Jr., ChairIndependent Regulatory Review Commission333 Market St., 14th FloorHarrisburg, PA 17101

RECEIVED2000OCT2O AH & 13

Original: 2064

Dear Mr. McGinley,

On behalf of the 2200 pediatrician members of the Pennsylvania Chapter ofthe American Academy of Pediatrics (PA AAP), I write to offer my supportof the Revised Final Rulemaking 16A-49a of the Professional and VocationalStandards allowing certified registered nurse practitioners prescriptiveauthority.

Pediatric practices often employ CRNPs as practicing colleagues. Theseregulations provide for expanded authority in their practice of medicine butunder the supervision of a physician. This is consistent with the position ofthe PA AAP. The current revised language in the proposed final regulationswith regard to requirements of an advanced pharmacology course, the ratioof prescribing CRNPs to physicians and the waiver process is supported bythe PA AAP. We urge IRRC to accept the revised final rulemaking whichmaintains the collaborative practice relationship of nurse practitioners withphysicians.

Thank you for your consideration of these comments.

Sincerely,

TTkkiLu'Mar|fc S. Reuben, MD A yPresident /y

Cc: The Honorable Clarence D. BellChair, Senate Consumer Protection & Professional LicensureCommitteeSenate Box 203009Harrisburg, PA 17120-3009

The Honorable Mario J. Civera, Jr.Chair, house Professional Licensure CommitteeHouse Box 202020Harrisburg, PA 17120-2020

' 'Advocates For Children''

EMBARGOED MATERIAL

PENNSYLVANIA SOCIETY OF ANESTHESIOLOGISTS

Original: 2064

October 17,2000

ChairpersonIndependent Regulatory Review Commission333 Market Street14th Floor 1 CO

9?

O

3Harrisburg, PA 17101

Dear Chairperson:

I write as President of the Pennsylvania Society of Anesthesiologists (PSA) to urge yoursupport of the proposed final rulemaking pertaining to prescriptive authority for CertifiedRegistered Nurse Practitioners (CRNPs). An earlier version of this proposed rulemakingwas rejected on July 14, 2000 by the Independent Regulatory Review Committee (IRRC)as being too restrictive. The State Boards of Medicine and Nursing have subsequentlyaddressed the concerns raised by the IRRC in its previous disapproval of the regulations.The compromises agreed to by the Medicine and Nursing Boards include liberalizing thepharmacology course work requirement, increasing the ratio of prescribing CRNPs tophysician supervisor, and a waiver to the regulations in special circumstances.

The Pennsylvania Society of Anesthesiologists believes that the compromise proposedrulemaking is both fair and reasonable. These rules, if passed, will appropriately expandthe scope of practice of CRNPs while ensuring adequate physician oversight in a mannerthat will preserve and protect patient safety. The Pennsylvania Society ofAnesthesiologists strongly urges your adoption and approval of this proposed finalrulemaking.

Very truly yours,

Stephen R. Strelec, M.D.President

SRS/sb

INDEPENDENT REGULATORYREVIEW COMMISSION

To:Agency:

Fax:

From:

>mpany:

Suzanne HoyDepartment of StateLicensing Boards and Commissions7-26287-0251

Kristine M. ShomperDeputy Director for AdministrationIndependent Regulatory ReviewCommission(717) 783-5419 or (717) 783-5417(717)783-2664

Date:# of Pages:

Embargoed Mail received.

October 18, 20004

Original: 2064

EMBARGOED MATERIAL

Pennsylvania Academy ofFAMILY PHYSICIANS

PresidentKevin P. Shatter, MD

President-ElectMark D. Burd, MDDanville

Vice-PresidentPaul D. Williams, DOHarrisburg

TreteurecRonald I. Buckley, MDAllentown

Immediate Post PresidentChristine M. Stabler, MDLancaster

Executive Vice PresidentJohn S. Jordan

RECEIVED

2IBOCTI9 AM 8:36

REYiCv /COh i i a j ^ ^

John R. McGinley Jr., ChairmanIndependent Regulatory Review Commission14th Floor, 333 Market St.Harrisburg, PA 17101

October 17, 2000

Dear Mr. McGinley:

On behalf of the more than 4,700 members of the Pennsylvania Academy of FamilyPhysicians, I wish to convey our support for the proposed final rulemaking providingprescriptive authority for certified registered nurse practitioners (CRNPs).

Pennsylvania's family physicians want CRNPs given the regulatory authority toprescribe medications, as is their legal right under the Medical Practice Act.Permitting such, within the context of a collaborative agreement and under physiciansupervision, is an outstanding patient benefit which we have supported since theinitiative was introduced so long ago. We also support the recent amendments offeredby the state boards of Nursing and Medicine to meet those concerns raised by IRRCat its July hearing on these regulations.

Your thoughtful consideration of our position is appreciated. Please contact me at mypractice at 814-838-3405 should you have any questions about the Academy'sposition on this issue. I look forward to being part of the first generation of physiciansin Pennsylvania able to work beside prescribing CRNPs, Thank you.

Sincerely,

^d.

Kevin P. Shaffer, MDPresident

Cc:The Honorable Clarence D. Bell, Senate Consumer Protection & ProfessionalLicensure Committee ChairmanThe Honorable Mario J. Civera, Jr., House Professional Licensure CommitteeChairmanWanda Filer, MD, PAFP Public Policy Commission Chair

2704 Commerce Drive Harrisburg, PA 17110-9365

vo id 717.564.5365 TOLL FREE 800.648.5623 FAX 717.564.4235 www.pafp.com

OCT-17-2000 17=40 610 520 9177 P.WZ

AmericanAcademy ofPediatrics

Pennsylvania Chapter

Rowmont Bwwma* Campu*Wuildmg 2. Suilc 107

Roicmom, J»A 19010A10/520-0123 Fax 610/520-9177;.*AW3-PAAAP

Murk S. Reuben, Ml) .Ruicling Pcdiiilrii:*40 Berkuhirc CourtWyomiiiiing, PA 19610610/374-7400 Fax 610/374-1641

Vice President

J. Chiton Gartner, M.D.Children V Hospital of Pittsburgh3705 Filth AvunuuPilLsbu^i, I'A 15213412/AV2-513SRIK412/6V2-7O3H

Sttcnuury TreasurerRobert Ciceo. M.D.WsNfem PA Hwpital4X00 f'rti«n«khip Avunu«Suiw N-3'120PilwbliHil., I«A 1522.14!2/f7R-!*5K Fax 412/578-152^

Mtmbrnt At LurRe

T. Dcnnte Duwgcn. M.D.Dickmn Cilyi W\

Barbara P. Homclcr, MI) .Sclkrsviite, PA

Anthony A Luboili, M.D.Philadelphia. PA

Alkn S.NuHRbaurti. M.lX

Macy Ann K:gu^ M.D.Coudcr&port PA

Eva I1. Volley, M.D.OibSu.na. PA

Paxt Prrsidmt

Bradley J. BmUfM, M.D.Pitttbuffih. PA

lixficutive mremr%\Ltax\<K c:. Yunyluns

traffic Inptry Prevention Project

Jcpold M. Anmwm. M.D.. M.P.H.

Rmrij ChUJf^ad EduwthrtUnknw SystemSusan S. Aronsoru M.D.

immmtiiOlhn Education rntgremAlun U. Kohrt> M . a

SmufitfQf C&xarbn Prvunm

linfiitKh l> Willis. M.D.

C*U4 Pwrl* Ittvkn' Pr*#nmDavid Turkeml/., M.D.

CfiUd Ahux* Education Program

CiiHiyChriKlian.M.IT

October 17,2000 EMBARGOED MATERIALOriginal: 2064

RECEDEDJohn McQnley, Jr., ChairIndependent Regutatory Review Commission ZOBO OCT 17 Pff 5:24

Harrisburg, PA' 17101 REVIEW c o M i # i o ^ Y

Dear Mr. McGinley, oOn behalf of the 2200 pediatrician members of the Pennsylvania Chapter ofthe American Academy of Pediatrics (PA AAP), I write to offer my supportof the Revised Final Rulemaking 16A-49a of the Professional and VocationalStandards allowing certified registered nurse practitioners prescriptiveauthority.

Pediatric practices often employ CRNPs as practicing colleagues. Theseregulations provide for expanded authority in their practice of medicine butunder the supervision of a physician. This is consistent with the position ofthe PA AAP. The current revised language in the proposed final regulationswith regard to requirements of an advanced pharmacology course, the ratioof prescribing CRNPs to physicians and the waiver process is supported bythe PA AAP. We urge IRRC to accept the revised final rulemaking whichmaintains the collaborative practice relationship of nurse practitioners withphysicians.

Thank you for your consideration of these comments.

Sincerely, J

Mark S. Reuben, MDPresident

IMJ

Cc: The Honorable Clarence D. BellChair, Senate Consumer Protection & Professional LlcensureCommitteeSenate Box 203009Harrisburg, PA 17120-3009

The Honorable Mario J. Civera, Jr.Chair, House Professional Ucensure CommitteeHouse Box 202020Harrisburg, PA 17120-2020

' 'Advocates For Children''

TOTAL P.02

OCT-17-2000 17:40 610 520 9177 P.01

919 Conestoga Rd.t BWg. 2 - Ste. 307, Rosemonl, PA 19010Phon*: (010) 520-9123 Fax (610) 520-81T7E-mafc paaap^volcenctcom

PA. Chapter,American Academyof Pediatrics

FaxOriginal: 2064

EMBARGOED MATERIAL

DUuMt Qferltevlnr DHNM(

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1 £ '

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INDEPENDENT REGULATORYREVIEW COMMISSION

To: Suzanne HoyAgency: Department of State

Licensing Boards and CommissionsPhone 7-2628

Fax: 7-0251

From: Kristine M. Shorn perDeputy Director for Administration

Company: Independent Regulatory ReviewCommission

Phone: (717) 783-5419 or (717) 783-5417Fax: (717)783-2664

Date: October 18, 2000# of Pages: 4

Embargoed Mail received.

DONALD H. SMITH, MDPresident

CAROL E. ROSE, MDPresident Elect

HOWARD A. RICHTER, MDVice President

JAMES R. REGAN, MD

JlTENDRA M. DESAI, M DSecretary

ROGER F. MECUMExecutive Vice President

777 East Park Drive

P.O. Box 8820

Harrisburg, PA 17105-8820

Tel: 717-558-7750

Fax: 717*558-7840

E-Mail: stat@pamedsoc.org

www.pamedsoc.org

PennsylvaniaM E D I C A L SOCIETY

October 16, 2000 Original: 2064

»0CT/6 W | : so

Mr. John R. McGinley, Jr., ChairIndependent Regulatory Review Commission333 Market St., 14th FloorHarrisburg, PA 17101

Dear Chairman McGinley:

I am writing as President of the Pennsylvania Medical Society in support of the proposedfinal rulemaking, pertaining to prescriptive authority for certified registered nursepractitioners (CRNPs), submitted jointly by the State Boards of Medicine and Nursing. Iunderstand that these proposed regulations will be presented to the Independent RegulatoryReview Commission (IRRC) at the next meeting. The Society believes that the amendedregulations address concerns expressed by commentors and by the IRRC in its order ofdisapproval of the previously submitted proposed regulations.

We support the more flexible requirements for training and experience in advancedpharmacology proposed by the Boards. We also agree with the suggested revision relatingto the number of prescribing nurse practitioners a collaborating physician may supervise.These changes are more reflective of current practice situations while protecting the publicfrom inappropriate levels of care.

The Pennsylvania Medical Society urges approval of the nurse practitioner prescribingregulations submitted to IRRC for consideration.

Sincerely,

Carol E. Rose, MDPresident

Cc: The Honorable Clarence D. Bell, Chair,Senate Consumer Protection and Professional Licensure Committee

The Honorable Mario J. Civera Jr., Chair,House Professional Licensure Committee

Charles D. Hummer Jr., MD, Chair,State Board of Medicine

DNM/doc/cor/McGinley2000

OriglMl: 20M EMBARGOED MATERIALFax received 10/18/00 @ 11:29

PENNSYLVANIA COALITION OF NURSE PRACTITIONERSPENNSYLVANIA STATE NURSES ASSOCIATION

PENNSYLVANIA ALLIANCE OF ADVANCED PRACTICE NURSES

October 16, 2000

Robert Nyce \: ggExecutive Director nv' S ^Independent Regulatory Review Commission R § m333 Market Street ? — OHarrisburg, PA 17101

Re: 16A-499, State Boards of Medicine and Nursing

Dear Mr. Nyce, j 4*

S?

The Pennsylvania Coalition of Nurse Practitioners, the Pennsylvania State Nurses Association and theAlliance of Advanced Practice Nurses appreciate the many hours of attention given by you and othermembers of the Department of State to the CRNP regulations amendment. As you know, we werewilling to support the proposed regulations published in the PA Bulletin in October 1999. However,we objected to those provisions that appeared in the regulations for the first time in final form or werechanged significantly in the final form as it was initially approved by the Board of Medicine and theBoard of Nursing.

At the present time, after a second final form version has been approved by the Boards, we can acceptthe new wording allowing a combination of courses to reach a requirement of 45 hours of advancedpharmacology content. However, we must go on record regarding the most recent revision on twopoints: physician "supervision", and the limited ratio and waiver.

Physician supervision

In the previous version of the amendment, after much discussion during the March, 2000 public jointmeeting of the Boards, section 18.57 and21.287 were titled "physician collaboration". Now the titlehas been changed back to "physician supervision".

Limited ratio and waiver

Even after our strong expressions of concern and the IRRC disapproval, sections 18.57 and 21.287continue to impose a ratio of physician to CRNPs. In our opinion the Boards have not justified thisratio as directed by IRRC As we have stated before, imposing ratios disrupts the delivery of healthcare in a multitude of settings, including physicians' practices, hospitals, clinics and agencies wheremany nurse practitioners are currently employed. The malpractice rate for nurse practitioners in theUS is less than 2%, far lower than that for physicians. There is no evidence that ratios will ensurequality health care for patients of physicians and the nurse practitioners with whom they collaborate.

As we noted in a previous letter, in an institutional or free standing health care facility, it is commonfor an individual or group of CRNPs to have a collaborative agreement that, in effect, covers theCRNPs and a number of physicians. Under the new rules, it is assumed that the requirements inSections 18.61 and 29.291 authorizing written standard policies and procedures would apply toprescribing nurse practitioners in those settings. If this is not the case, modifications in the ratio andthe collaborative agreement requirements would need to be made to recognize the realities of theCRNP physician relationships in those settings similar to those provided in Sections 18.61 and

Conclusion

We are cognizant of the considerable time, effort and energy that have gone into the development ofthese regulations jointly promulgated by the Boards of Nursing and Medicine. We realize that there islittle we can do to change these regulations at this time. Nurse practitioners in Pennsylvania verymuch want to join their colleagues in the 48 other states who are able to sign their own prescriptions.However, we feel we must go on record regarding the above stated difficulties in the latest version ofthe CRNP regulations.

\Asincerely,

JatlTowers PhD, CRNP, ChairPennsylvania Coalition of Nurse Practitioners

KSWbrJe&e Rohner, DrPH, RN, Executive AdministratorPennsylvaniarState Nurses Association

Melinda Jenkins, PhD, CRNP, Co-chairPennsylvania Alliance of Advanced Practice Nurses

Melinda Jenkins, PhD, CRNP504 Yale Ave.

Swarthmore, PA 19081610-543-3483

October 9,2000Original: 2064

Sen. Joseph LoeperSenate Box 203026Harrisburg, PA 17120

Dear Senator Loeper,

I am a Family Nurse Practitioner residing in your district. I teach master's students in the Schoolof Nursing at the University of Pennsylvania and I provide patient care as a fully credentialedprimary care provider at a nurse-managed health center in Philadelphia. I urge you to contact theIndependent Regulatory Review Commission to ask them to disapprove the revised amendmentto the CRNP regulations that were recently voted upon by the Boards of Nursing and Medicine.I am aware that the language of the amendment was changed slightly after the IRRC disapprovaland continued negotiation of the Boards. However, I have grave concerns about inconsistenciesin the process of the revision and about the effects that the regulations as currently worded willhave on access to essential health care. I strongly urge the Senate and the IRRC to disapprovethe regulations based on the following issues that are critical to the health, safety, and welfare ofthe citizens of the Commonwealth:

1. Ensure access to care by eliminating the CRNP: physician ratio.The ratio limitation is a substantive change that was added after the close of the October 1999public comment period on the proposed regulations. When objections to the ratio were raised bythe regulated community and by IRRC, it was enlarged from 2:1 to 4 CRNPs :1 collaboratingphysician. The Chair of the Board of Medicine and the Physician General have defended theratio by raising hypothetical and undocumented abuses of CRNPs by physicians. Even thoughdirected by IRRC on 9/11/00 to "amend or delete this requirement or explain why it isappropriate", the Boards have not justified a ratio with any firm evidence that it is necessary toprotect the health, safety, and welfare of the citizens of the Commonwealth. My guess is that theratio was inserted in the regs to appease a tiny minority of conservative physicians who do noteven practice with CRNPs but who believe they need protection against competition in thehealthcare marketplace.

There are only two other states known to have ratios; both are higher than 4:1 "at any giventime". If our ratio in Pennsylvania is limited to "any given time", collaborative agreementsbetween a single physician and more than 4 CRNPs may be filed with the Boards. Given part-time and flexible work schedules, how will the Boards know which people are collaborating "atany given time"? This most recent revision to the CRNP regs will place the Boards in theembarrassing position of having a regulation for which the need is not substantiated and whichcannot be enforced.

Access to care is clearly threatened by this tiny ratio, by the fact that a physician—not a CRNP—must apply for the waiver, by the lack of definition of "good cause" for a waiver, and by theundefined process to obtain a waiver from the ratio. Representatives of the Dept. of State havebeen asked several times to clarify procedures and criteria for a waiver and have never given aclear answer (see the minutes of the March 15,2000 joint meeting of the Boards and the minutesof the June 13,2000 House Professional Licensure Committee). The ratio and the vague waiverboth contradict the Boards9 claim in their May 26,2000 Regulatory Analysis Form that "thisrulemaking is expected to result in greater availability of quality, cost-effective health careservices". / believe that the ratio and its waiver are indefensible and should be totallyeliminated.

CRNP practices and nurse-run centers across the state provide essential health care forunderserved rural and urban populations. Many of these practices can be recognized by theirMedicaid, Title X, and CHIP reimbursement as well as by their large volume of uncompensatedcare. Most of these centers are staffed with multiple part-time CRNPs, are affiliated withschools of nursing, hospitals, and other reputable agencies, and hold numerous collaborativerelationships with more than one physician. Unbiased research has shown their patient outcomesto be equal to or better than those of physician practices. Prescribing CRNPs should not beforced to pay the expense of a totally arbitrary number of physician collaborators. PrescribingCRNPs should not be at the mercy of physician-initiated waivers to be determined withoutspecific criteria by Boards with a history of over 20 years of stalemate regarding CRNP practice.

2. Maintain the statutory Board authority over CRNP prescription of medical therapeuticsinstead of shifting to an individual collaborating physician the authorization to identify drugcategories that a CRNP may prescribe and dispense. The revised regulations require that thecollaborative agreement "identify the categories of drugs from which the CRNP may prescribe ordispense " and "contain attestation by the collaborating physician that he or she has knowledgeand experience with any drug that the CRNP will prescribe." Thus, the revised regulations pinthe responsibility and potentially very costly liability for each and every prescription upon thecollaborating physician.

I agree with Barbara Safreit, Associate Dean of Yale Law School, who wrote, "Once the statehas legally recognized the APN [Advanced Practice Nurse] as a competent provider, it is oddindeed to condition practice upon the agreement or permission of a private individual.. Any statethat adopts such a mechanism has in effect yielded its governmental power to one privateindividual, the physician,. .At worst, [such schemes] constitute a wholesale privatization of acore governmental function: assessing competence for licensed practice." (p. 452) [Safreit, B.J.(1992). Health care dollars and regulatory sense: The role of advanced practice nursing. YaleJournal on Regulation, 9.417-490. ] Please note that Professor Safreit wrote her analysis of theregulation of nurses in 1992. She wrote to reveal national inconsistencies in a state'sresponsibility to protect the public by licensure of appropriately educated professional nurses andits bowing to the heavy-handed influence of physicians to restrict advanced nursing practice.

3, Use the term "collaboration" rather than "supervision" as agreed upon in the March 15,2000 joint public meeting of the Boards of Nursing and Medicine. The latest version of the

i

CRNP regs ignores an agreement that the Boards made in public, after much discussion, duringthe March 15,2000 joint meeting to the title of section 21.287 [ 18.57] "PhysicianCollaboration". Now the title and its meaning have been changed to "physician supervision".According to the existing CRNP regs, CRNPs practice "in collaboration with and under thedirection of9 a collaborating physician; the word "supervision" does not apply. Quietly changingthe final form of the regs to reflect the opposite of what was agreed upon in the joint publicmeeting by using the term "supervision" in regard to prescription of medical therapeutics (drugs)further restricts the practice of CRNPs and the public's access to our care.

Thank you for your attention to these concerns. Please ask IRRC to disapprove the regulationsas they are written and return them to the Boards for further negotiation and collaboration withthe regulated community. It is essential for the Boards to represent the interests of the regulatedcommunity as they protect the health, safety, and welfare of Pennsylvania citizens. As youknow, House Bill 50 was introduced last year in part to avoid such laborious negotiations in thejoint promulgation of regulations for CRNPs by the Boards of Nursing and Medicine regardingadvanced practice. It still seems to me to be the most sensible strategy for each profession to beregulated by its own board. Please contact me if you would like further information.

Sincerely,

Melinda Jenkins, PhD, CRNPFamily Nurse Practitioner

CC:

Robert Nyce, Executive DirectorIndependent Regulatory Review Commission333 Market St., 14th FloorHarrisburg, PA 17101

Governor Tom Ridge225 Main CapitolHarrisburg, PA 17120

Representative Mario Civera, ChairProfessional Licensure CommitteeHouse of RepresentativesPO Box 202020Harrisburg, PA 17120-2020

Senator Clarence Bell, ChairConsumer Protection & Professional Licensure CommitteeSenate Box 203009Harrisburg, PA 17120

Mr. Steve Anderson, ChairPennsylvania Board of NursingDr Charles Hummer, ChairPennsylvania Board of MedicinePO Box 2649Harrisburg, PA 17105-2649

PENNSYLVANIA CHAPTER,

AMERICAN COLLEGE OFEMERGENCY PHYSICIANS

777 East Park DriveP.O. Box 8820Harrisburg, PA 17105-8820http://www.paacep.org Original: 2064

(717) 558-7750888-633-5784

FAX (717) 558-7841dblunk@paacep.org

BOARD OF DIRECTORS

C. JAMES HOLLIMAN. MD. FACEPPresident — Hershey

ARTHUR C. HAYES, MD, FACEPPresident-Elect — Blue Betl

BRUCE A. MACLEOD, MD, FACEPVice-President - Pittsburgh

MARC J FINDER, MBA, MD, FACEPTreasurer — Buffalo Mills

MARILYN J. HEINE, MDSecretary — Bristol

RICHARD P. O'BRIEN, MD, FACEPPast-President — Scranton

ROBERTA. CAMERON, MD, FACEPPhiladelphia

THEODORE CHRISTOPHER, MD. FACEPPhiladelphia

WILLIAM C.DALSEY,MD, FACEP

HARRY E. KINTZI, MD, FACEPLancaster

RICHARD F. KUNKLE, MD, FACEP

DOUGLAS F. KUPAS, MD, FACEP

ROBERTS. PORTER, MD, FACEPPhiladelphia

WALTER A. SCHRADING, MD, FACEP

MATTHEW'1 WATSON, MD

DAVID BLUNKExecutive Director

October 12,2000

Robert Nyce, Executive DirectorThe Independent Regulatory Review Commission14th Floor, 333 Market StreetHarrisburg, PA 17101

Dear Mr. Nyce:

On behalf of the Board of Directors of the Pennsylvania Chapter, American Collegeof Emergency Physicians, I would like to relay that Pennsylvania ACEP is insupport of the revised final rulemaking of the State Board of Medicine and the StateBoard of Nursing regarding prescriptive authority for Certified Registered NursePractitioners (CRNPs) (16A-49a).

We believe the recent revisions adequately address the concerns of organizedmedicine, and we urge the Independent Regulatory Review Commission to approvethe revised regulations.

Sincerely,

^ - / ##^

C. James Holliman, MD, FACEP ;President I

o

# ;

INTERNATIONAL HEADQUARTERS: P.O. BOX 619911, DALLAS, TEXAS 75261-9911WWW.ACEP.ORG

.<*»YUH

"VR**'

PennsylvaniaPsychiatric Society

The PennsylvaniaDistrict Branch of the

American Psychiatric Association

PresidentJeremy £ Musher, MD

President-ElectLawrence A. Real, MD

Past PresidentL**C. Miller, HD

Vice PresidentKenneth ML Ceria, MD

TreasurerRogerF.Hask*tt,MD

SecretaryMaria RuizaYee,MD

Executive DirectorOwen Yackee Lehman

777 East Park DriveP.O. Box 8820Hamsburg, PA

17105-8820

(800) 422-2900(717)558-7750

FAX (717) 558-7845E-mail glehman@pamedsoc.org

www.papsych.org

Original: 2064

R E CEIV E 0

2008OCTI2 &HIQ:09

REviLWCOMMISSION'"

Oct. 6,2000

Robert Nyce, Executive DirectorThe Independent Regulatory Review Commission14th Floor, 333 Market StreetHarrisburg, PA 17101

Dear Mr. Nyce:

I am writing on behalf of Jeremy Musher, MD, the President of the PennsylvaniaPsychiatric Society, in support of the revised final rulemaking of the State Board ofMedicine and the State Board of Nursing regarding prescriptive authority for CRNPs(16A-49a).

The regulations in this revised, final form adequately address the concerns weexpressed in regard to proposed regulations published in the Oct. 2,1999 issue of thePennsylvania Bulletin. We urge the Independent Regulatory Review Commission toapprove the regulations.

Sincerely yours,

JL^. &*Gwen Yackee LehmanExecutive Director

cc: Jeremy S. Musher, MDLois Hagarty, Esq.

RECEIVED

1641 Pine Ridge Lane 2 # SEP ~5 &% 8= 3 5Effort, PA 18330 _ , _ _ n r r > ! ! /.TORYSeptember 1, 2000 - ^ ' REVIEW COMMISSION

Honorable James J. Rhoades < |';• ^Senate 203029 - - ~ "Harrisburg, PA 17120-3029

O r i g i n a l : 2064Honorable Sir:

I am a new comer to Effort, Pennsylvania. Additionally I am a geriatric nurse practitioner with 14 years ofpractice and am coming into what appears to be the tail-end of a protracted effort to achieve prescriptiveprivileges for nurse practitioners in the state of Pennsylvania.

My previous state of practice was Maryland and prescriptive privileges have been in place, at least duringmy time as a nurse practitioner. 1 was quite surprised when apprised regarding the status of the same inPennsylvania. I want to adamantly show my support for the nurse practitioner movement for prescriptiveprivileges.

As part of my effort to support this endeavor, I have two major concerns with the regulations underconsideration. The regulations, as currently stated, require that nurse practitioners demonstrate that theyhave successfully completed a 45-hour course in pharmacology. I understand the intent of the requirement,but believe it needs to be reworded. Nurse practitioners should be required to take and document 45 hoursof pharmacology before prescriptive privileges are granted. However, this requirement should becumulative and not limited to one specific course. Until quite recently it was not uncommon forpharmacology to be integrated throughout the course content of the of the nurse practitioner program, asopposed to one freestanding course. As stated in the regulations this 45-hour pharmacology course wouldbe punitive to practitioners with the most experience in the prescribing of medications. I do not believe theintent was punitive, but rather an oversight. I would request that you write the Independent RegulatoryReview Commission (IRRC) in support of my request that the regulations be reworded to reflect aminimum of 45 hours of advanced pharmacology cumulative total, not limited to one specificpharmacology course.

The second area of concern is the regulation that a physician not serve as the collaborating physician formore than two nurse practitioners. I see this restriction as an insult to both the physician and the nursepractitioner. Both individuals have much at stake (personally and professionally). I do not believe thatthey need an overseer to make a decision on their behalf as to the limits of their collaborative practices. Ifurther believe that as dedicated professionals they will self-monitor and if the circumstances show that thecollaborative arrangement is not in the patients' best interest and safety corrective steps will be taken.Physicians and nurse practitioners have a long history of collaborative practice that has provided qualitycare to patients without this type of regulatory oversight. I am requesting that you write the IRRC andrequest that the regulation limiting the number of nurse practitioners with whom a physician cancollaborate be eliminated.

The third aspect of the regulations on which I would ask your support is that you request the IRRC tofollow the verbal agreements of the Boards (Nursing and Medicine) to allow nurse practitioners toprescribe unclassified therapeutic agents, medical devises and pharmaceutical aids.

My final request is related to the maintenance of the statutory Board authority over nurse practitioner actsof medical prescription. There has been movement to shift this authority to the physician with whom thereis a collaborative agreement. Such a change would place prescriptive responsibility on the collaboratingphysician both from a clinical and liability perspective. Additionally, this approach would serve to addconfusion to the role and practice scope of the nurse practitioner. Nurse practitioners are educated andtrained in critical thinking and prepared to assume responsibility for their prescriptive acts. Monitoring ofsuch acts should remain within the purview of the Board.

I appreciate your taking time to consider my requests and trust that you will contact the IRRC.

Very truly yours,

Catherine Caruso, MSN

John R. McGinley, Jr., ChairmanIndependent Regulatory Review Commission

Rep. Mario CiveraChairman, House Professional Licensure CommitteeRoom 315D Main CapitolHarrisburg, PA 17120

Rep. William ReigerDemocratic Chairman, House Professional Licensure CommitteeRoom 327 Main CapitolHarrisburg, PA 17120

Senator Clarence BellChairmanSenate Consumer Protection and Professional Licensure CommitteeRoom 20 East Wing, Main CapitolHarrisburg, PA 17120

Senator Lisa BoscolaDemocratic ChairmanSenate Consumer Protection and Professional Licensure CommitteeRoom 183 Main CapitolHarrisburg, PA 17120

Governor Tom Ridge225 Main CapitolHarrisburg, PA 17120

Pagel ofl

IRRCFrom: Catherine Caruso [ccaruso@enter.net]

Sent: Friday, September 01, 2000 2:45 PM

To: irrc@irrc.state.pa.us; boscola@dem.pasen.gov

Subject: Ref. No. 2064--NP regs

Please see copies of letters attached.

Original: 2064

p

6

06

I

9/5/2000

PENNSTATESchool of Nursing

Original: 2064

August 15, 2000

The Pennsylvaniia State University201 Health and Human Development EastUniversity Park, PA 16802-6508

(814)863-0245Fax:(814)865-3779

:

t

I«

mo

John R. McGinley Jr., ChairmanIndependent Regulatory Review Commission \ @ ;

333 Market St., 14th FloorHarrisburg, PA 17101

Dear Mr. McGinley:

This letter is written to express opposition to the CRNP Regulations approved byIRRC on July 13, 2000. The ratio limitation, added after the close of the October1999 public comment period on the proposed regulations, threatens access tocare for many clients. Persons affected by this limitation have had noopportunity to respond to this severe problem. The ratio should be eliminated.

Advanced pharmacology hours should be 45 hours each year, calculated in asummative manner. One single 45 hour offering is not as effective as ongoingsmaller incremental coursework. The initial documentation of hours needs torequire a total of 45 hours within the past 3 - 5 years.

It is essential to maintain the statutory Board authority over CRNP acts ofmedical prescription, instead of shifting the authorization to identify drugcategories that a CRNP may prescribe and dispense to the collaboratingphysician. The initial October 1999 regulations listed only 5 classes of drugs thata CRNP might prescribe with authorization documented in the collaborativeagreement; 17 classes were allowed to be prescribed "without limitation11. Thechange made in the March 15, 2000 document to list 21 classes of drugs thatmust be authorized by collaborative agreement, places accountability on thecollaborative physician, when liability should be assigned to the provider of care.This change was made after the public comment time period and should beeliminated.

College of Health and Human Development An Equal Opportunity University

-2-

I have practiced in two other states in the advanced practice role of Family NursePractitioner. Both states allow prescriptive privileges within regulations thatenabled the Nurse Practitioner to truly provide care and be an accountablemember of an interdisciplinary clinical practice. The late changes in restrictionsundermine the ability of advanced practice nurses to be effective providers inPennsylvania and restrict the access to care that could be improved bysupportive regulations. In truth, these regulations impose restraint of trade onadvanced practice nurses and severely limit their ability to provide effective care.

Sincerely,

C^L^^JLj£Carol A. Smith, DSN, RN, FNP, CSAssociate Director,The Pennsylvania State University School of Nursing201 Health and Human Development EastUniversity Park, PA 16802-6508

Gelnett, Wanda B.

From: MarnettaB@aol.comSent: Tuesday, August 15, 2000 4:53 AMTo: irrc@irrc.state.pa.usSubject: CRNP Regs: IRRC Reference # 2064

Marnetta Bradofrdf MSN, CRNP93 Armstrong Dr. Original: 2064Shavertown, PA 18708

John R. McGinley Jr., ChairmanIndependent Regulatory Review Commission

August 14, 2000

Dear Mr. McGinley,

I am writing to you in regards to the CRNP regulations that are up

review by the Independent Regulatory Review Commission (IRRC). I want

be aware of the concerns I have regarding the current proposedregulations. Iam a family nurse practitioner living in Shavertown and practicing in a

family practice in Wilkes-Barre. My concern is that the regulations as

currently stand will unnecessarily limit the practice of the nursepractitioner thereby limiting access to care by the patient.

The current proposal recommends that there be a 2:1 CRNP tophysicianratio. Access to care is clearly threatened by this tiny ratio, by the

that a physician (not a CRNP) must apply for the waiver, by the lack ofdefinition of "good cause" for a waiver, and by the undefined process to

obtain a waiver from the ratio. The ratio should be totally eliminated.The second point of the regulations is that nurse practitioners must

completed a 45-hour pharmacology course. Most nurse practitioners have

completed one discrete 45-hour pharmacology course. However thesummation oftheir advanced pharmacology hours in addition to other pharmacologyhours intheir course work and/or continuing education hours does equal to or isgreater than 45 hours. Defining the advanced pharmacology hours toinclude 45

hours in total rather than 45 hours in one course would allow credit for

previous or subsequent coursework even though it may not have been all

course. Please consider summation of advanced pharmacology hours to

45 hours. This will minimize costly tuition and time lost from work for

who have been safely practicing for years.

I recommend that the verbal agreement of the Boards to allow CRNPprescription of unclassified therapeutic agents; medical devices;

pharmaceutical aids be supported.

I support maintaining the statutory Board authority over CRNP acts ofmedicalprescription instead of shifting to an individual collaboratingphysician the authorization to identify drug categories that a CRNP mayprescribe and dispense. As published in October 1999, the regulationslisted only 5 classes of drugs that a CRNP might prescribe withauthorization documented in the collaborative agreement; 17 classes wereallowed to be prescribed "without limitation". A substantive change wasmade in the March 15, 2000 document to list 21 classes of drugs thatmust be authorized by the collaborative agreement, Thus, the revisedregulations pin the responsibility and potentially very costly liabilityor each and every prescription upon the collaborating physician.Again, the affected regulated community and the public have not had theopportunity to comment on this substantive change.

Please consider the above concerns when the proposed regulations come up

Sincerely,

Marnetta Bradford, MSN, CRNP

RECEIVED9211 Palmer Rd. 2090 AUG H AM 8:56North East, PA 16428 _ „ , , T 0 R Y

August 13, 2000 REVIEW COMMISSIONOriginal: 2064 .... @

Dear Mr. Anderson,I am writing to urge that you work with the Boards of Nursing and Medicine to

revise the jointly promulgated regulations regarding CRNP prescribing.I was so relieved to hear that IRRC had disapproved of the regs and that the two

Boards agreed to work on the 45 hour pharm course requirement and the ratio. I'd loveto see the proposal changed to include 45 cumulative hours of pharmacology, or toallow for a test that could check CRNPs knowledge of medications and prescribing. I'dsuggest that the ratio of MDs to NPs be entirely removed.

Please come up with adjustments that will permit CRNPs to practice withoutcreating unnecessary barriers to our authorization to prescribe and our collaborationwith physicians.

Sincerely,

Sue Murawski, CRNP

Dr. Charles Hummer, Chair State Board of Medicine

Rep. Mario Civera, Professional Licensure Committee

Rep. William Reiger, Professional Licensure CommitteeSenator Lisa Boscola, Consumer Protection & Professional Licensure CommitteeSenator Clarence Bell, Consumer Protection & Professional Licensure CommitteeGovernor Tom RidgeRep. Tom ScrimentiRobert Nyce, Executive Director IRRC

Nor*MM,** M M

Page 1 of 1

Gelnett, Wanda B.

From: WRIGHT SARA [SARI@prodigy.net]

Sent: Saturday, August 12,2000 11:15AM

To: irrc@irrastatespa.us O r i g i n a l : 2064

Subject: IRRC Ref.#2064:ATTN: John McGinley Jr., Chair

Dear Chairman McGinleyI want to thank you for disapproving the regulations regarding Advanced Practice Nurses & Prescriptiveauthority that was presented to the committee. As you are well aware, these contained items that were notprovided the appropriate comment opportunity normally provided such matters. I have attached a copy of theletter sent to my Representative that outline the concerns I have regarding the proposed regulations. Iappreciate your continued efforts to resolving the prescriptive issue for Advanced Practice Nurses.Sara Wright, MSN,CRNP

8/14/2000

Representative Paul W. SemmelHouse Post OfficeState CapitolHarrisburg, PA 17120August 12, 2000

Dear Representative Semmel-I am writing to support the recent Independent Regulatory Review Commission's (IRRC,reference # 2064) disapproval of the proposed regulations for prescriptive authority forAdvanced Practice Nurses. Although I am delighted that both the Board of Nursing andthe Board of Medicine have made significant efforts to address this issue over the pastseveral months, the regulatory proposal that was presented contained issues that werenot present in the draft that was offered for public comment. Those issues are notacceptable to most of the Advanced Practice Nurses in our State. These issues include:

• The arbitrary ratio of Nurse Practitioner to Physician limit set at 2:1. Forsome practice settings that serve needy populations in our State, this maynegatively impact access to care to many of the Nurse Managed clinics thatoperate with higher ratios. A specific ratio is not necessary, as there arecurrently JTQ instances of Nurse Practitioner/ Physician practice methodsthat actually support a reason to set a ratio limit in the regulation.

• Evidence of discrete 45 hours of advanced pharmacology education: Icertainly support the intention of this item, however, many educationprograms that Nurse Practitioner's completed had the Pharmacologycontent spread throughout the course of study as most medical educationalcourses do. I believe that if the Advanced Practice Nurse can provideevidence of a cumulative total of 45 hours, it should be sufficient to meetthe intent of this particular item.

• Disapproved version of the regulations did not allow for the verbalagreement of the Boards to allow Nurse Practitioners prescription ofunclassified therapeutic agents, medical devices and pharmaceutical aids.This issue is best left up to the Boards established in the State, rather thanby a yet to established alternative.

It is hoped that when these regulations are reviewed, they are opened to commentfrom the Boards. The items above should be easily addressed if the Boards areprovided with that window of opportunity (seven days) to do so. It is my hope thatthe next version of the regulations presented for your vote contains the acceptablemeans to address these issues. I thank you for your consideration of these matters.With Appreciation,

Sara Wright, MSN, CRNPCc: K. Stephen Anderson, Chair, BON

Charles D. Hummer, Chair, BOMMario Civera, Chair, House Prof. Use. Com.John R. McGinley, Chair, IRRC

Gelnett, Wanda B.

From: Lori Martin Plank [lmp@epix.net]Sent: Friday, August 11, 2000 11:37 AMTo: irrc@irrc.state.pa.usSubject: RE: IRRC#2064

To Mr. John McGinley, JR.Copy of Letter to Chair of Board of Nursing90 Ervin RoadPipersville, PA 18947-9391 Original: 2064July 20, 2000

K. Stephen Anderson, M.Ed.,CRNAChairperson, State Board of NursingP.O. Box 2649, Harrisburg, PA 17105-2649

Dear Mr. Anderson:

I am a certified registered nurse practitioner, currently working in acommunity-based nursing center, and also in a community-based, mobilehealth unit. In both of these settings I work with underserved, poor,minority populations with little or no health coverage. In order to

maximum service to our clients and to be cost effective, we are all perdiem employees. We have a collaborating physician, but our situation

be seriously and adversely affected by your current ratio of 2 nursepractitioners to 1 physician. There are 6 to 7 nurse practitioners,including our director, in the one setting. We do not earn a lot ofmoney,but our work is very rewarding, and we feel that we are making a majorcontribution to health care for disadvantaged, and, in the long run,helping them to learn self-care and self-sufficiency, and preventchronicillness burdens on the health care system. Hiring additional physicianswould require that money earmarked for clients be used to pay physiciancosts, and less clients would be served.

I am writing to urge you, in your capacity as Chairman of the Board ofNursing towork with the Board of Medicine to revise the regulationsjointlypromulgated by the Boards regarding nurse practitioner prescribing. ,

The recent disapproval of these regulations by the IndependentRegulatoryReview Commission provides an opportunity for both Boards to affect acompromise agreement that will allow CRNPs to prescribe. Specifically,please remove the 2:1 ratio of CRNPs to physicians and the requirement

all CRNPs must have a discrete 45 hour pharmacology course in order toprescribe. By the Commonwealth's own estimate 40 percent of CRNPs do notreach this requirement. Please provide another way to demonstratecompetency for those CRNPs who do not have a discrete 45 hour course.

For over 25 years the two Boards have not been able to reach agreement

these jointly promulgated regulations. Now that they are so close toclosure, please work to come up with a compromise on these issues that

be more workable for CRNPs who wish to prescribe. CRNPs in Pennsylvaniaare eager to join their colleagues in 47 other states who have attained

this long standing goal.

Thank you for your consideration of this request.

Sincerely,Lori Martin Plank, RN, MSPH, MSN, CRN?

Golden Care of Northeast PA, Inc.Michelle M. Bernard!, UN.

Director of Administration & Professional Services65 Bryden St., Pitiston, PA 18640

Original: 2064 July 19,2000 V?

Dear Sir or Madam:

This letter is m support of revision to the current Certified Nurse Practitioner regulations. Pleaseconsider the following:

• Because Ac 2 CRNP: 1 physician ratio will greatly inhibit access to health care for rural and poorerindividuals elimination of this requirement would benefit an already disadvantaged population

• Allowance of summation of advanced pharmacology to include 45 hours in total rather than 45hours in one course will minimize costly tuition and time lost from work for CRNP'swho have beensafely practicing for years.

• Follow the verbal agreement to allow prescription of unclassified therapeutic agents, medicaldevices, and pharmaceutical aides

• Maintain statutory Board authority over CRNP acts of medical prescription to identify drugcategories that a CRNP might prescribe

Sincerely,

JKUJUM^TT)>&****£',£*>Michelle M Bemaidi, R.N.Nurse Practitioner Student

(570)654-2883 (800)747-0113 Fax:(570)883-9709 GCNEPA@A0L.COM

Original: 2064

, . . . i f <\:$ft?rses Enrichment Services to America}M JUL 1 ' r.»'« -• J Germantown Health Committe

4 i40 £. C^M/^r Sta?e*, Philadelphia, PA, 19144tfpmten Maiti&t: foUner Humphrey, RN, JD July 12, 2000

Robert Nyce, Executive Director, Independent Regulatory Review Commission333 Market St., 14th Floor, Harrisburg, PA 17101Re: Health Policy, ethics and practices in Pennsylvania as related to Nursing Profession

Information Deprivation in Philadelphia for past four decades and Public HealthUnfair manipulation of policy related to Nursing Practice in PA and USA

Dear Mr. Nyce,I am alarmed about possible changes to the CRNP regulations for consideration on

July 13! I was alerted by a recent WPEN broadcast Upon follow-up, I note that proposedchanges are not in the best interests of nurses and those we serve. It should be disapproved!

Nurses who are advanced in administration, law, journalism and home-making areeasily isolated from vital information in Philadelphia! A lack of timely access to career-relatedinformation and policy changes is a disservice to the most valuable players in the ancient andvital service of tender loving care, without which no modern society can ever be fully human!

Nurses Enrichment Services to America is a trust group serving families of the Firstand Second Congressional Districts of Pennsylvania since 1968. Initiatives include OperationKinship (voluntary public access broadcast series), 1968 to 1991, WDASAM& FM. Mothersare our most valuable players in home-making today! Adolescents are pivotal decision-makersin every self-governing society! Urban 2eneralist values rely upon the nursing profession! Weoperate through acceptance of symptoms we may not subjectively feel and diagnoses we maynot fully define. We accept a patient's view of what ails him or her and a qualified physician'sview of what needs attention! We design, implement and oversee care plans that appreciate,cultivate and ultimately accomplish, the healing purpose! We often develop requisite skills todiagnose, prescribe & manage treatment, residential care, follow up and health maintainance!

The late DK Finton Speller, (who served as PA Health Secretary under late governorMilton Shapp) informed us about threats to our health infrastructures in local communities.Policy modifications in health-related professions needed more caution and serious publicattention. I am fortunate and thankful to have been a colleague of his during that time.

Governor Shapp also created a State level Committee for Health in PA prisons andappointed me to that body. PA developed a Professional Standards Review process for healthcare consistent with then HEW Secretary, Califano^s efforts to sustain and enrich our federalhealth oversight, interactive with state level policies, towards a more perfect union for us all!

Please disapprove the CRNP regulations amendment! I am available and eager todiscuss this important matter with you and colleagues at your earliest possible convenience.

Sincerely,Dr. Mattie L. MtiUtiMpttr®, I^oj^MialWumanicc: USA Justice Department: Phildelphia Regional Office, Natiokai Office

Family Interdisciplinary Ecumenical Task Force of Wister, Philadelphia, PAYouth Voters League, First Congressional District PA, 12th ward, 9 divisionInterested others

M. L. Humphrey, RN, Esquire

PRESERVE OUR REPUBLIC! GROW OUR DEMOCRACY!

NATIONALSOVEREIGNTYof the UnitedStates of America, is vested in the federalgovernment and is manifested within the will ofthe electorate.

DEMOCRACY, is a cooperative and localizedprocess which upholds self-sufficiency of theindividual within context of the good of thewhole!An ever evolving general and specmctunctonof the USA DEMOCRACY is to help guide thefunctional development of minor USA residentsas self respecting and socially responsiblehuman beings.

The expressed interests of the ELECTORATEare our most PRIMARY VALUE; and must betaken at the highest level of seriousness by allofficials in publicly funded actions, decisionsand policies!

The will of the electorate is betrayed when theestablished electoral process is not effectivelyimplemented by responsible officials andparties. The sovereign will of the electorate isintended to enable RIGHTTO MAKE MIGHT!

The several founding Republics retain specificsocereignty as articulated in the enabling andfounding documents, including the Bill ofRights, of the United States of America.

Corporate expression of corporate interestsimpacts society directly via local marketplaces; and also through administration ofstate and local laws pertaining to authorityand conduct of specific corporations as theyare licensed by the particular state or statesso licensing.

The USA, as a self-serving government amonggovernments, exists as the official instrumentschampion for those under its jurisdiction, thosecertain inalienable rights created in naturalpeople by the Natural Generative Force andFertility of Our Universe as experiencedthrough our natural universal creation!The sovereignty of the USA society, respectingcitizens and guests thereof, is vested in theelectors of tlhis nation, and must be expressedthrough the official electoral process as it ismade known to the eligible elector.

It is in the interest of the USA that the integrityof the electoral process be respected, main-tained and preserved at every level of societyand therefore is a duty held by every active/acting governmental servant/agent!

When in the USA, an elector presents info toany Licensee (federal communications law)showing a pattern of an unlevel playing fieldfor members of political parties over indepen-dent voters, a Licensee should publish suchevidence and its source at no cost withoutincurring liability for the content as stated.

Electoral procedures of the USA and localstates are as sacred to this Democracy, itsidentity, its integrity, and its conduct as arespecific scriptures sacred to specific and ororthodox religions upheld by any citizen of thisdemocracy!

Any beneficiary of This Democracy holdingno personal love, loyalty, allegiance or duty tothe foundation principles of this manifestsociety is not entitled to share in the generalwelfare of any State of this democracy or ofthp nation iteplf

Natural numan expression OT electors asspecific personal sovereignty is to be mani-fested through the electoral process for local,state and federal levels of legislative, executiveand judicial levels of governance.

Access to timely, relevant, authenticInformation Is the

KEYSTONE of OUR DEMOCRACY!

Freedom of speech Is guaranteed under theFirst Amendment To The Articles of Incorpo-ration of The United States Constitution.

The enumeration In the Constitution of certain rightsshall not be construed to deny or disparage others retained by the people!

SSL

AGJ3NERICPLATFORM byMatticLMUncrHumphrey,Nuisc/AttorocyFirst used in

EquityFairnessQuality

andAccountability

OPERATION KINSHIP•A full time home-maker is micro-manager of family social values,serving as a most valuable playerin "inner city games", wherebytrue democracy works as the basicself-government for all players!

"A government which has power to tax a man in peace, draft him m war, should have power to defend his life in thehour of peril A government which can protect and defend its citizens from wrong and outrage and does not is vicious.A government which would do it and cannot is weak; and where human life is insecure through either weakness orviciousness in the administration of law, there must be a lack of justice, and where this is wanting, nothing can makeup the deficiency."Frances Ellen Watkins Harper of the National council of Women in the United States, February 22,1891.

Take the liberty!Pcrscveie!

Have the Patience!Make democracy work!

DemographicTools of Sustainable

Community Development

Legal IssuesService vs Insurance

"Coverage"

Techniques of division,strife, oppression and

social instability

wholeness of a human being

shelter & sanctuary of a self

development of community

functional development

integrity of cultural identity(per kinship basis)

• HEALTH

• HOUSING

• EDUCATION

• EMPLOYMENT

• WORLD VIEW

• fragmentation

• redlining

• indoctrination

• functional "training"

* economic class as a"mainstream system"

A. production of the PhiladelphiaUrban Self Study Institute

March 12,1998

*IY DEFENSE OFHOMEMAKEBS is a political platform addressing the media and the politicians. I know now thatpoliticians are not interested in what I feel about the vulnerability of our democracy. I also know that the majorplayers on THE GREAT INFORMATIONHIGHWAYHAVELITTLE REGARD FOR THE VALUE OF city girls. CityGirls live in OURCTIY, USA, THE CRADLE OF LIBERTY. We are raising children who are not all destined to be"leaders". They are being raised to be decent human beings."

The marketplace woos children with fantasies and promises. The switch and bait system t&_ faster than the speed oftight* *We~.rear children with inadequate sanctuary from the abstractions, illusions, deceptions, etc. of markets whichare freer than most decent human beings. * "For City Girls When the Confusion Is Too Clear* M. Humphrey, RN-Esq~SOULMATES Publishing Cooperative, PhihL, Pa. P.O. Box 29617, Philadelphia, Pennsylvania 19144 (215-438-7314)

Ninth Amendment Coalition: Youth Voters League ProjectFirst Congressional District of Pennsylvania, 12th ward, 9th division

The Amadou Dialllo Curriculum for Global JusticeCorrespondence Course at SCI-Graterford, initiated June 20, 2000

MattieL. Humphrey, RN/Esquire, America's # One Volunteer!An informative Introduction prepared for United States Attorney General

Honorable Janet RenoHealthy housing, education and welfare policies have operated in the lastfifty years against the best interests of Philadelphia's neediest residents!

A Citizen Request: please examine public policy uses and abuses in Philadelphiawith special reference to the actual use of health, housing, education andwelfare funds allocated by Congress to the county of Philadelphia. It seems thata) public funds are controlled by regional corporate ffleaders ";b) Policy tends to sabotage local traditional civil service systemsc) Policy funds self-serving private agencies to compete with local civil servicesd) Policy is not open to involvement of qualified and professional city residentse) Policy is a deal of both political parties collaborating with private investors

Objectives of this Youth Voters League:to grow our democracy in each local community (village) and householdto preserve a republic within each state, commonwealth, and territory

Basis: Declaration of Independence, USA Constitution, Bill of RightsOur nation is a self-governing independent corporate entityEach natural person is a member of the human familyEach family unit is a self-defining, self-developing cooperative social enterpriseIncorporated entities are man-made vested interest "citizen-like" lesal fictions(Private corporations tend to share civil privileges but not the human deficits!)

Refer: The enumeration in the constitution of certain rights shall notbe construed to deny or disparage others retained by the people.

Note: local communities have been altered by transportation and communicationstechnologies to an extent that local infrastructures are no longer compatiblewith or subservient to the families and communities of Philadelphia as a city.

Inequities: The most rewarding employment is generally held by non resident people.The value of public resources is defined in context of national aggregates.Such services are distinct, unique and localized time-place-person systems.Legally, such a system is subject to resident peers, not commodity markets.In Philadelphia the reverse is true! Many qualified people are unemployed!

Injustices: Citizen debts outstanding as taxes and loans are sold as commercial paper.This is especially oppressive in Philadelphia during the last fifty years.Residents are routinely subject to extensive drug and behavior research!Families and communities are uninformed of actions, results or benefits!

Self-serving neighborhood systems have been devoured by opportunists!Issue: How do policies that govern people apply to "citizen-like" entities?

Example: local public utilities are self-service agencies under a body of resident peersproviding essential public services to sustain the general welfare of said body as acooperative and self-sufficient entity.They are self-cooperatives, not private vendors!

»

SPORTS TODAY

TPI METRO PA • PHILADELPHIA * THURSDAY, MARCH 9, 2000

Smoltz is outfor seasonwith injury• TORN ELBOW LIGAMENT PUTSA DENT IN BRAVES' WORLDSERIES HOPES PAGE M

City's exodus continuesStudy says heart drug

BOSTON About 1,566 U.S. heart attack^victims tiiay die needlessly each year

These drugs - TTA, streptokinaseand Retavase — are standard treat-ment for patients who arrive at theemergency room within six hours ofthe start of symptoms. Given quickly,the drugs can clear the way of bloodclots before permanent damage isdone. Last year, the medicines weregiven to about 260,000 heart attack

- *; ~n ts in the United States. (AP)

Surrounding counties gaining population at Philadelphia's expensePHILADELPHIA The latest county-by-coun-ty census estimates for 1999 show thatonce again Philadelphia was the biggestpopulation loser.

The Census Bureau estimates show thatPhiladelphia continued to hemorrhageresidents, losing 17,367 people .for thestate's largest percentage decline of 1.2percent. Allegheny County also rankedclose to the bottom, losing 11,157 people

for a 0.9 percent drop in population. Bothcities have launched major downtownTeyitalizations and other efforts to try tokeep people from leaving.

The counties around Philadelphia,however, continue to gain at the city'sexpense/Chester County ranked third inpopulation growth, attracting 8,128 resi-dents, while Bucks County gained 6,184

. residents and Montgomery County gained

4,518. Delaware County, however, lost resi-dents. The Pocono-mountain Pike andMonroe counties were the fastest-growingin the state. Many new Pocono residentscommute by car or bus to jobs in NewJersey and New York City, and increasinglyto the Lehigh Valley, officials said. Overall,the state's population declined for theyear, losing 8,313 residents to drop below12 million as of July 1999. (AP)

My state of mind is a true, clear, constant and vigilant witness of my here and now!

URBAN SELF STUDY INSTITUTEAMADOU DIALLO FORUM

"STATE OF MIND"

"EVERY TARGET NEED NOT BE A VICTIM!"

M. L. HUMPHREY, R.N., M.H .A., J.D.DEGREES OF CAPTIVITYDATE: JULY 11, 2000

Topic: "City's Exodus Continues", metro headline, Thursday, March 9,2000Comment: "Elections do not make a democracy!*' Mattie L. Humphrey, July 11,2000

Germantown Health Committee Self-analysis by SCI-G: Degrees of Captivity membersA course promoting health as self-consciousness, self-knowledge, well-being and sanity.

Current events and public policy. We grow in a specific place during an explicit time.• How do you feel about Philadelphia, Pennsylvania today (from a distance, I know)?• What is meant by the word "Exodus" in the headline presented here?• What facts herein are news to you, familiar to you, or difficult for you to understand?• Does a "hemorrhage" of residents from Philadelphia effect you or your life-style?• Does PA's loss of 89,313 residents have any direct impact on your current situation?• What is meant by "elections do not make a democracy" as stated by MLH above?• Is the phrase Billy Penn 's holy experiment familiar to you? If so, discuss briefly.• Have you heard of "bipartisan policy" before? If so, discuss. If not, question it now!• What is the Mason-Dixon Line, what does it do, and where is it located? Why is it?

Public Policy and how we evaluate our situation in context of our objective environment.• Does Philadelphia, as described, reflect/resemble anything that is happening to you?• Why is loss of population considered a hemorrhage?• What role does economics play in quality of life of residents in cities?• Would a seasonal sports arena determine whether you would go or stay in a city?• What proportion of current jobs in Philadelphia are held by commuters?• How many Philadelphia residents are overqualified, yet under-employed here?• Why did health and hospital care change into profit-making insurance benefits?• Why did public schools stop teaching home economics?• Why are neighborhood families out of the loop in curricula and other vital areas?

COMMON SENSE 2000: A New CurriculumOPERATION KINSHIP: Viewing the Millenium

GLOBAL HUMANITY pleads for re-direction of attitudestoward a common planetary resource system! Our Futurecalls us from gross self-destruction! Can we learn thebehavior of an intelligent, resourceful and ever evolvingspecies of life within an ecosystem of multiple life-forms!Are we over-awed by the numbers, complexity and oddvariety of life forms with which, and with whom we shareour vital interaction and our essential common beingness?

COMPETITION, control and domination are oftenregarded as first and ultimate imperatives by mankind!Challenge, opposition, trial, conflict and conquest oncedominated strategies of our cave-man ancestors! Now,these tools no longer constitute a tenable presumptiveauthority or determinant of social mores, political optionsor moral imperatives. These premises, as standards, arenot acceptable for our most meaningful social encounters,behaviors, and interactions in this new era now aborning!

DAWN brings a more Divine Consciousness to ourwakeful expanding spirit! We cautiously sense a morerefined energy lifting us above popular, but mean, spirits!

Are we, who have so long submitted to a kill or be killedreflex mentality, now to become capable of a live and letlive modus operand! of social life?

MLH/MM

A!

Original: 2064

ALEKSANDRA A. MCDONNELL

R2000 JUL •9-.38

ION'

3010 Perm View LaneTrooper, PA 19403

610-539-8381

June 12,2000

Robert Nyce, Executive Director, IRRC333 Market Street 14th floorHarrisburg, PA 17101

Dear Mr. Nyce:I am a CRNP practicing for 14 years in a pediatric clinic for the under and uninsured patients. I worktwo days/week. One of the days is spent as a health consultant in a child care center I am writingbecause the proposed regulation changes are unfair. They would be an exceptional burden to try tofulfill the requirements. Our clinic is funded by the United Way, the county health department, andlocal townships. I make a minimal salary as per deim employee with no benefits as do the other fournurse practitioners. This helps keep the cost manageable for the office. I am certified by ANCC andI am required to acquire 75 contact hours every five years. I accomplish this through conferences andprofessional meetings. I am a member of our pediatric nurse practitioner group. I also read variouspediatric journals on a monthly basis. I feel I am very qualified in my position. I do minimalprescribing of antibiotics. I do maximum counseling about nutrition, safety, discipline, first aid.

The specific 45 hour Pharmacology course, 16 hours biennially of Pharmocology credits, the limitedformulary, and the 2:1 CRNP to MD ratio would mostly likely cause me and other part-timeemployees to stop practicing as NPs because the cost and time expended would be prohibitive.Noone tells the MDs what their CEU credits need to be in. Addtionally, only a small number of NPare jointly promegated in other states by the BOM and the BON. NPs in all but about five states haveprescriptive authortity. Quality of care is not enhanced by overwhelming regulations. Patient care isnot necessarily improved because someone has CEU credits in pharmacology.

Lastly, follow the language of the American Hospital formulary to list each and every drug categoryin the book. The missing language of the American Hospital Formulary cited to list each and everydrug category in the book. The missing categories must be inserted as drugs a CRNP may prescribeand dispense. These categories were discussed in the March 15 joint public meeting of the Boardsand their inclusion was a condition of the Board of Nursing's March 30 vote to approve theregulations. They are: "eye, ear, nose, and throat preparations; hormones and synthetic substitutes;oxytocics; unclassified therapeutic agents; medical devices; pharmaceutical aids". Furthermore, therevised regulations require the collaborating physician to attest "that he or she has knowledge andexperience with any drag that the CRNP will prescribe." Thus, the revised regulations pin theresponsibility and potentially very costly liability for each and every prescription upon thecollaborating physician. Again, the affected regulated community and the public have not had theopportunity to comment on this substantive change.

These are the reasons I have concerns about the regulations. Please reconsider them; these are toorestrictive and will affect access to care for our clinic patients. Thank you.

Sincerely,

Aleksandra A. McDonnell, RN, MSN, CRNP

07/11/2800 07:58 7172450953 MORGAN PLANT PAGE 02

JOl-11-00 TUB 6:50 AM E.T.G1IM FAX NO. 7177616764 P, 1

Original: 2064

Listed below are the practice configurations existing in this Hate that would be obstructed by a2:1 nurse praetiuonerfphysician collaboration ratio.

Nurte managed clinicsHospital Departments where multiple nurse practitioners are used for the provision of medicalservices (Includes outpatient departments, ncomtul units, chronic care units much as oncologydepartments, emergency rooms and critical care units)Private practices utilizing more than two nurse practitioners (of which there are many)Rural Health Clinic*Federally Qualified Health CentersMigrant Clinic*Family Planning ClinicsLong Term Care facilities

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07/11/2808 07:58 7172450953 MORGAN PLANT

mM_\\ fu 1 8:U623911REViiLV. iur.r.lSSlON

Morqan Plant &Associates322 S. West StreetCarlisle, PA 17013

717-245-0902 (voice)

717 245-0953 (fax)

mrgnplantuAOL.com

T* John Jewetttoc783-2664

Urgent for R#v@#w

Fr©mi Morgan

Ff*»t 1

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2000

# Comments

This Is the list of practice configurations that Jan Towers pulled together.

HUSP1IAL HSSUC Ul- PH 10=717-561-5334 JUL 11'00 12=19 No.001 P.02

HAPTHE HOSPITAL & HHALT1ISYS r VM ASSOCIATION OF PENNSYLVANIA ^

O r i g i n a l : 2064 c

July 11,2000 2000JULH AM 10: 06

Mr.JohnR.McGinley,Jr. REVi . ucn^WiONChairman GIndependent Regulatory Review Commission333MaiketStJwt14th Floor, Hanistown #2

Harrisburg,PA 17101

RE; 16A-499, State Boards of Medicine and Nursing

Dear Chairman McGinley:The Hospital & Healthsystem Association of Pennsylvania (HAP), on behalf of itsapproximately 250 member hospitals and health systems, supports the final-formregulations jointly submitted by the State Board of Medicine and the State Board ofNursing that establish the requirements under which certified registered nursepractitioners (CRNPs) may prescribe and dispense medications in Pennsylvania. HAPencourages the Independent Regulatory Review Commission's approval of theseregulations.

More than 25 years ago, a law was enacted in Pennsylvania granting CRNPs prescriptiveprivileges upon adoption of regulations governing those privileges. As you well know,Pennsylvania is one of the last few states in the country to establish prescriptive authorityfor CRNPs—this, despite the essential role that CRNPs have in providing primary care,particularly to undcrserved populations across the state. HAP believes that the approvalof these regulations would benefit Pennsylvania citizens and that failure to adopt theregulations at this time would likely derail this opportunity to meet patient needs foranother extended period of time.

While HAP, in general, supports approval of the regulations, we still have some on-goingconcerns regarding the limitation on the number of CRNPs per collaborating physicianand the education requirement* for prescriptive authority.

Limitation on Number of CRNPs Per Collaborating Physician

Sections 18,57 and 21,287 prohibit a physician from collaborating with more than twoCRNPs at the same time, if those CRNPs prescribe and dispense medications. Theregulations do permit a physician to ask for a waiver to this limitation for "good cause/'The provision on limitation of the number of CRNPs per collaborating physician was notcontained in the proposed regulations, thus preventing public comment and constructivedialogue about the reasonableness of this standard,

4750 Uadlc IU*dRO Rox86OO))urri*bn.g,PA 17105- 8600717.564.9200 Phone7I7..SM .5334 Faxlit (j >://www.hap2000.mfl

HOSPITAL PSSOCOFPf. 1D.717-561-5334 JUL 11-00 J 2 a 9 N o . 0 0 1 P . 0 3

HAP

2OBQ JUL 11 » G 6John R. McGinley, Jr.

Z"-*™ ""KM — %HAP believes that the 2:1 limitation could increase the cost of care and limit access tocare in undeserved communities. While the State Board of Medicine has stated thatprescriptive authority will be a new function for CRNPs, in reality, physicians andCRNPs have been collaborating to meet patient needs for prescriptions through otherapproaches and arrangements. Therefore, we do not believe that these regulations willrequire new responsibilities for the collaborating physician.

The State Board of Medicine also has expressed concern that unless some limitation isplaced on the number of prescribing CRNPs with whom a physician may collaborate, aphysician could enter into collaborative agreements with too many CRNPs, creatingunsafe patient care. There has been no evidence presented that this would likely occur orthat exceeding the 2:1 limitation will pose harm to patients.

While HAP recognizes that the waiver provision in the regulations may potentiallyaddress our concern, neither board has identified the circumstances or criteria that wouldbe used to evaluate a waiver request Absent clarity regarding the waiver process, HAPis concerned that there will be inconsistent approaches to responding to waiver requestsby each of the boards and because of that, the decision-making process will not be timelyin its response to community health needs. Further dialogue on this issue is neededbetween both boards since the regulations provide no guidance on what might constitutereasons for good cause or the criteria that might bo used to evaluate such requests.

Education Requirement for Prescriptive Authority

Sections 18.53(2) and 21,283(2) require a CRNP, who wishes to prescribe and dispensedrugs to complete s specific course in advanced pharmacology, which is approved byboth the State Board of Medicine and the State Board of Nursing and is not less than 45hours in length.

HAP supports that CRNPs be adequately educated and trained in prescribing anddispensing drugs for the patient population that he or she cares for, including requiring adiscrete pharmacology course in the CRNP formal education process, HAP alsorecognizes that many CRNPs practicing today did not complete such a course as part oftheir education. We do believe, however, that for many of these CRNPs, the coursescompleted in their formal education program, their continuing education, and their yearsof actual practice provide the knowledge and experience needed to prescribe and dispense jmedications without having to now take another 45-hour course, HAP supports Iestablishing the 45-hour requirement in CRNP programs for currently enrolled students,but believes both boards need to consider alternative ways for actively practicing CRNPs

HUSPl.RL HSSUU Uh PH ID: m-bbl-WJ* JUL ll'UU 12 W NO.UU! K.U4

ilAI

to demonstrate competency in the prescription of drugs. Additionally, both boards shouldprovide guidance on which courses would qualify CRNPs to exercise prescribingauthority and how the CRNP educational programs should proceed to receive approvalfor these courses.

HAP, again, reiterates its general support for these regulations. Should the IndependentRegulatory Review Commission oppose the regulations, we would urge the Commissionto request that the boards remove sections 18.57 and 21.287 from the regulations prior tosubmission of the regulatory package for Commission approval. The Commissioncould then encourage the boards to consider promulgating a separate regulation on thesetwo sections to enable a more thorough debate and public dialogue regarding whethersupervision limitations need to be established, and if so, what reasonable limitationswould be, and finally, what criteria would be established for waiving those limitations.

We appreciate the opportunity to provide our comments. Should you have any questionsregarding the above comments and recommendations, please contact Betsy H. Taylor,Director, Legal and Regulatory Services, at HAP, at (717) 561-5526 or via e-mail atbtavlor@hap2000.org,. or Lynn Gurski-Leighlon, Director, Clinical Services, at HAP, at(717) 561-5308 or vi* e-mail at teleiKhion@hap2000.org.

ly.

.S^I^WwPAULAA.BUSSARDSenior Vice President, Policy and Regulatory Services

c: Herbert Abratnson, Legal Counsel, Bureau of Professional and Occupational AffairsK. Stephen Anderson, CRNA, Chairman, State Board of NursingClarence D. Bell, Chairman, Consumer Protection and Professional LicensurcCommittee, PA SenateHoward A, Burde, Esq., Deputy General Counsel, Office of General CounselRobert Cameron. Esq., Legal Counsel, State Board of NursingDorothy Childress, Commissioner, Bureau of Professional and Occupational AffairsMario J. Civera, Jr., Chairman, Professional Liccnsure Committee, PA House ofRepresentativesCharles Hummer, MD> Chairman, State Board of MedicineGerald Smith, Legal Counsel, State Board of MedicineJames Smith, Analyst, Independent Regulatory Review Commission

HOSPITAL RSSDC OF PA ID:717-561-5334 JUL ll'OO 12:1* NO.UU1 K.O1

MAIQF^'^n

JUL 11 AM 10:06% E HOSPn^L&HEAmiSYSTEM ASSOCIATION OP PENNSYLVANIA A ;• y4750 Lindie Road ' \{ £ y 11 ,v C J rU ; 1S U i 0 K

PO Box 8600H^rrisburg, PA 17105-$«00717.564*9200 Phone717-561*5334 Faxwww,hap2000,org

FAX TRANSMISSION

^ page(s), including cover sheet

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SUBJECT:

MESSAGE:

JUL-11-^WWW ^ j : j b P.W^/WJ

UNIVERSITY of PENNSYLVANIA

School of Nursing Norma M. Lang, PhD, RN, FAAN. FRCN

nflS^pTlttOMOM Original: 2064 S ^ S * * Smo« Dean of N«r«HFax: 215-573-2114

^ j S C ^ L EMBARGOED MATERIAL

July 11,2000

John R. McGinley, Jr., Chairman _.,"' SIndependent Regulatory Review Commission ^ ^ "O333 Market Street r p '14th Floor ; — ' -:Harrisburg, PA 17101 s" ^ '

IRRC Reference #2064 - "-

g: = -DearMr.McGinley: . ^ ; "

It is with mixed emotions that I write on behalf of the faculty and students of the University ofPennsylvania School of Nursing. First, the efforts to implement prescriptive privileges foradvanced nurse practitioners is most welcome by the entire nursing profession and we applaudthe efforts of the Commonwealth's Board of Nursing and Board of Medicine m this area.However, we have major concerns regarding the CRNP regulations that are currently before theIRRC

Of greatest concern is the two CRNP: one physician ratio that was added after the close of theOctober 1999 public comment period on the proposed regulations. Not only does this ratio createprofound limitations on advanced practice nurses but, more importantly, it significantly reducesaccess to care for the citizens of Pennsylvania. This is particularly true in rural and underservedurban areas of the state where advanced practice nurses provide much needed care. In the Schoolof Nursing's Penn Nursing Network, a consortium of nurse owned/managed practices, advancedpractice nurses are providing primary health care to the poorest members of the Philadelphiaurban communities. Their efforts have mended many ties in these communities where citizensfelt themselves forgotten and disenfranchised by more traditional health care avenues. The newregulations will prevent these citizens from receiving the type of care that they have now becomeaccustomed to and ties now bound will be broken once again. The only solution that will servethe public, who have not had an opportunity to comment, is to completely eliminate this ratio.

JUL-11-2000 23:36 P.03/03

EMBARGOED MATERIM*.

John R. McGinley, Jr

July 11,2000

Our second concern is the change to the statutory authority over CRNP's regarding the numberof drugs they are permitted to prescribe without authorization by a collaborating physician. In theearlier regulations, they were permitted to prescribe 17 classes '"without limitation." There wereonly five classes of drugs that required authorization by a collaborating physician. Once again,after the public comment period, this was changed to 22 classes of drugs requiring physicianauthorization. Surely, this does not do service to the public who will have to wait for theirprescriptions until a physician can personally approve them. This is an unnecessary delay when aCRNP could have properly prescribed them at the start- In addition, this regulation restrictsadvanced practice nurses in their efforts to provide quality care and places greater burdens onphysicians who will have to shoulder the fiill responsibility and liability for every prescription. Itis difficult to see its advantage.

Also of concern is the number of hours in an advanced pharmacology course the regulations nowrequire—45 hours in one course. This is an onerous requirement for those nurses that have beenpracticing safely for years. It will place an unnecessary burden on them and their families, aburden in time and a significant financial burden. Changing the regulation to a summation ofadvanced pharmacology hours to credit a total of 45 hours over a five year period would allowcredit for previous knowledge gained

Since so many important changes have been made without the opportunity for comment, we feelit is imperative that the regulations be disapproved and sent back for further consideration. Thegood health of the citizens of this State are at stake.

Thank you for your consideration of these important issues.

Sincerely,

4^*-Nonna M. Lang

5

TOTAL P.03

JUL-11-2000 23:35

UNIVERSITY- OF PENNSYLVANIASchool of Nursing

Nursing Education Building420 Guardian DITTO

Philadelphia, PA 19104-6096Telephone Number (215) 898-8283 Fax Number (215) 573-2114

NgrmaM. Lang, Ph.D., &#., FJULN., F.R.C.N.Professor

Margaret Bond Simon Dean of Nursing8

^ I/W^ft*A/>

q-/t£.C7 /

Date: / //^J/Vn/ /

RECEIVERS FAX NUMBER: r&ZT*^ % ~-o&ZW^

Number of pages including this coyer sheet: _JLMESSAGE

rr.^^.pD MATERIAL

Note: If you do not receive the cumber of pages indicated, please adviseimmediately via telephone.

AMJUL 10/00 20:48 766 282felcgates P&Zlofl

Original: 2064

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H-360.987 Principles Guiding AMA Policy RegardingSupervision of Medical Care Delivered by Advanced PracticeNurses in Integrated Practice

The AMA endorse* the following principles; (1) Physicians must retain authority for pathcare In any team care arrangement, e.g., integrated practice, to assure patient safety anquality of care,

(2) Medical societies should wort with legislatures and licensing boards to prevent dllutkof the authority of physicians to lead the hearth care team

(3) Exercising independent medical judgment to select the drug of choice must continuebe the responsibility only of physicians.

(4) Physicians should recognize physician assistants and advanced practice nurses urnphysician leadership, as effective physician extenders and valued members of thehealth care team.

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<5) Physicians should encourage state medical and nursing boards to explore the feasfbof working together to coordinate their regulatory initiatives and activities

(6) Physicians must be responsible and have authority for initiating and implementingquality control programs for nonphysldar* delivering medical care in integrated practice(GOT Rep. 23, A-96; Reaffirmation A-99)

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H-35.975 Ratio of Physician to Physician Extenders

Our AMA endorses the principle that the appropriate ratio of physician to physicianextenders should be determined by physicians at the practice level, consistent with goomedical practice, and state law where relevant (CME Rep. 10,1*98)

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Original: 2064

EMBARGOED MATERIAL1^0 '1 ' ^July 11,2000 2000 J l ' . 13 f.H 8: 52

Robert Nyce, Executive Director £ E y• L . ^ c_ .... - • Q - ,Independent Regulatory Review Commission222 Market Street, 14th Floor #Harrisburg, PA 17101

Dear Mr .Nyce,

I urge you to disapprove the amendment to the CRN? regulations that was recently votedupon by the Board of Nursing and Board of Medicine. I have significant concerns about theimpact these regulations will have on the access to health care for my patient population. Istrongly urge the IRRC to disapprove the regulations because of the following issues that are vitalto the welfare of citizens of Pennsylvania:(l) The ratio limitation of 1 physician to 2 CRNP'swould create significant hardship for my work setting and possibly result in access to care issuesfor patients (2) The requirement for "a specific course" in advanced pharmacology whichoverlooks the preparation of certain CRNP's who graduated from programs that had equalpharmacology integrated into their program (3) Specific missing drug categories would result inrestricting practice by CRNP's currently with expertise and need to prescribe certain drugs.(4)This proposed amendment does not allow for maintaining the statutory Board authority overCRNP acts of medical prescripion and instead shifts it to individual collaborating physicianswhich pins undue liability on collaborating physicians.

I am a nurse practitioner with 25years of experience providing quality patient care, 15 ofthose years as a nurse practitioner. I have worked in a college health setting for the past 14 yearsand have four nurse practitioner colleagues. We all work effectively in a collaborative relationshipwith our staff gynecologist. In 14 years of providing gynecology care this ratio has never beenproblematic. These regulation amendments under consideration, if approved would create thesignificant and unjustified necessity of changing a system that has been working well, with theexception of freedom to prescribe drugs and ultimately these proposed changes will be at theexpense of the patient.

Thank you for your attention to these concerns. Please disapprove the regulations as theyare written and return them to the Boards for further negotiation and collaboration with theregulated community.

Sincerely,

Jb Anna Moyer CRNP

cc: Governor Tom Ridge

Original: 2064

FMRARGOED MATERIAL R ! r r c " " ^July11'2000 mjp.\3m»skRobert Nyce, Executive Director ,-•-. L;

Independent Regulatory Review Commission KEVIEV; cuiinsSiOH222 Market Street, 14th Floor &$Harrisburg, PA 17101

Dear Mr.Nyce,

I urge you to disapprove the amendment to the CRNP regulations that was recently votedupon by the Board of Nursing and Board of Medicine. I have significant concerns about theimpact these regulations will have on the access to health care for my patient population. Istrongly urge the IRRC to disapprove the regulations because of the following issues that are vitalto the welfare of citizens of Pennsylvania:(1) The ratio limitation of 1 physician to 2 CRNP'swould create significant hardship for my work setting and possibly result in access to care issuesfor patients (2) The requirement for "a specific course" in advanced pharmacology whichoverlooks the preparation of certain CRNP's who graduated from programs that had equalpharmacology integrated into their program (3) Specific missing drug categories would result inrestricting practice by CRNP's currently with expertise and need to prescribe certain drugs.(4)This proposed amendment does not allow for maintaining the statutory Board authority overCRNP acts of medical prescripion and instead shifts it to individual collaborating physicianswhich pins undue liability on collaborating physicians.

I am a nurse practitioner with 14 years of experience providing quality patient care. I haveworked in a college health setting for the past 10 years and have four nurse practitionercolleagues. We all work effectively in a collaborative relationship with our staff gynecologist. In10 years of providing well woman and problem gynecology care this ratio has never beenproblematic. These regulation amendments under consideration, if approved would create thesignificant and unjustified necessity of changing a system that has been working well, with theexception of freedom to prescribe drugs and ultimately these proposed changes will be at theexpense of the patient.

Thank you for your attention to these concerns. Please disapprove the regulations as theyare written and return them to the Boards for further negotiation and collaboration with theregulated community.

Sincerely,

fJill Buchanan CRNP

cc: Governor Tom Ridge

Shomper, Kris

From: Sullivan-Marx, Eileen [eileens@nursing.upenn.edu]Sent: Tuesday, July 11,2000 9:36 AMTo: knss@IRRC.STATE.PA.US'Subject: RE: IRRC Reference #2064

Original: 2064

July 9, 2000

John R. McGinley, Jr.ChairmanIndependent Regulatory Review Commission333 Market Street, 14th floorHarrisburg, PA 17101

RE: IRRC #2064

Dear Mr. McGinley:

I am pleased that the Commonwealth's Board of Nursing and Board ofMedicinehave moved forward regarding regulations for prescriptive privileges fornurse practitioners. However, I have some serious concerns aboutspecificaspects of the proposed regulations that impede reasonable practice andplace an undue burden on citizens and providers of care.

1) A ratio limitation on the number of CRNPs that may practice with aphysician (2:1) is not tenable in practice. This is a substantive changethat has not been discussed adequately in public forums. There has been

precedent for such a limitation in Pennsylvania or any other state.

clearly places a limitation on access to care for Pennsylvania citizens,especially those served by Medicare and Medicaid. There are nocomparableregulations at the national level for Medicare reimbursement. In 1997,Congress passed the Balanced Budget Act granting direct reimbursement tonurse practitioners to ensure access of care to all Medicarebeneficiaries.

Limiting the number of practitioners in Pennsylvania that can practice

a specific physician will decrease access of care to Pennsylvania's

citizens.2) I also request that hours for advanced pharmacology education besummarized to 45 hours for several courses rather than in one course.

will minimize costly tuition and time lost from work for CRNPs who have

practicing safely for years.

3) Allow all CRNPs to have prescriptive privileges of unclassifiedtherapeutic agents, medical devices, and pharmaceutical aids. CRNPs arespecifically educated as nurses to promote function and independence forpatients. Ease of prescriptive authority to order such aids and devices

benefit Pennsylvania's citizens.

4) Maintain the statutory authority of the Board of Nursing for CNRPprescriptive privilege rather than place responsibility on individualcollaborating physicians. There has not been adequate public comment in

area of classes of drugs that CRNPs will prescribe. Currently, theregulations have been changed to allow 21 classes of drugs percollaboratingphysician. This is not consistent with other states or standard ofpractice.Classes of drugs should be regulated at the state level.

Thank you for your attention to these matters. I would be happy torespondto any questions at 215-898-4063 or email: eileens@nursing.upenn.edu.

Sincerely,

Eileen M. Sullivan-Marx, RN, CRNP, PhD, FAANAssistant ProfessorDirector, Adult Health Nurse Practitioner ProgramUniversity of PennsylvaniaSchool of Nursing

Original MessageFrom: kriss@IRRC.STATE.PA.US [mailto:kriss@IRRC.STATE.PA.US]Sent: Monday, July 10, 2000 8:28 AMTo: eileens©nursing.upenn.eduCc: jims@IRRC. STATE. PA.US; Management@IRRC. STATE. PA.USSubject: IRRC Reference #2064

We received an email from the above email address; however, noinformationwas contained in the message. If you want to comment on thisregulation,please do so before our blackout period (Tuesday, July 11, at 10:30

begins.

rage 1 011

Shomper, Kris

From: Susan Beidler [beidlsQnursing.upenn.edu]

Sent: Monday, July 10, 2000 12:55 PM

To: irrc@irrc.state.pa.us

Subject: Proposed CRNP regulationsOriginal: 2064

Dear Chairman McGinley,

I am writing to expressed several concerns regarding the proposed CRNP regulations.

First let me introduce myself. My name is Susan Beidler. I have been practicing as a professionalnurse in the Commonwealth of Pa since 1976 and as a Family Nurse Practitioner since 1981.1 amcurrently enrolled in a combined PhD in nursing and Masters of Bioethics program at the University ofPennsylvania. In addition to my clinical practice, I have held a variety of academic appointments andam currently a research assistant for a NIH/NINR funded study conducted by a University ofPennsylvania nurse researcher. My most recent clinical position was as a FNP at the Abbottsford andSchuylkill Falls Community Health Centers in Philadelphia for the past 5 1/2 years. Health centerssuch as these, and the vulnerable patients they serve, will suffer drastically from the proposedregulations.

The Abbottsford and Schuylkill Falls centers have been serving their respective communities for thepast 8 years and have been able to achieve impressive outcomes. This has been done with a model ofcare that has been both effective and recognized by the federal government through the "Models ThatWork" award program. These centers are staffed by several nurse practitioners, mostly part-time, incollaboration with one family physician. At no point in time did the issue of nurse practitioner tophysician ratio ever become a quality care or safety issue. It seems to me that this type of model, amodel that works, is what should be considered when attempting to create guidelines for ratios of NPsand physicians in collaborative practices. The imposition of a restrictive collaborative agreement, suchas mandating a 2 NP: 1 physician ratio, serves no one. This ratio is indefensible and should be totallyeliminated.

In addition, the establishment of a 45 hour course for pharmacology, rather than the recognition of thesummation of 45 hours of pharmacology content, imposes further unsubstantiated restrictions on theestablishment of pharmacology privileges for NPs. This further places a financial constraint on NPsand/or their employers for no good reason.

I strongly urge you to disapprove the CRNP regulations as they are currently written and return themto the boards for further revision.

Respectfully,

Susan M. Beidler MSN, CRNP, MSNFamily Nurse Practitioner &Predoctoral FellowInternational Center of Research for Vulnerable Women, Children and FamiliesUniversity of PennsylvaniaSchool of Nursing

7/10/2000

Shomper, Kris

From: Melinda Jenkins [mjenkins@smtp.nursing.upenn.edu]Sent: Monday, July 10, 2000 11:08 PMTo: irrc@irrc.state.pa.us; Mrgnplant@aol.com; 'SMShanaman@email.msn.com•;

'shanaman@worldnet.att.net'Subject: CRNP regs (#2064)

Original: 2064

PA HPSAs 5_97.doc Card for Melinda

A group of us met today with IRRC staff to discuss the CRNPregulations. We oppose the regs due to several reasons. The chiefreason is the 2:1 CRNP:physician ratio that will severely limit access

I have found on the internet a list of Health Professional ShortageAreas in Pennsylvania. 55 out of our 67 counties have at least oneshortage area.

Please see the attached file.Sincerely, Melinda Jenkins

From t h e web s i t e : www.shusterman.com/hpsa.html

Taken from the Federal Register May 30, 1997, vol. 62, #104, pp. 29395-29445.

Health Professional Shortage Areas

PRIMARY MEDICAL CARE: Pennsylvania County Listing

County NameAdams

Population Group: MFW—Adams/FranklinAllegheny

Service Area: Arlington Heights/St ClairService Area: Homewood-BrushtonService Area: ManchesterService Area: McKees Rocks-StoweService Area: North BraddockService Area: South BraddockService Area: West End PittsburghPopulation Group: Low Inc—Hill DistrictPopulation Group: Low Inc—MckeesportPopulation Group: Pov Pop—East Liberty

•ArmstrongService Area: Armstrong-ClarionService Area: Dayton/Rural ValleyService Area: Kiski ValleyService Area: New Bethlehem/HawthornService Area: Northeast Butler

Service Area: East Liverpool (OH/PA/WV)•BedfordService Area: Broad Top/CromwellService Area: Pleasantville

Population Group: Med Ind—Welsh Mountain

Service Area: Pleasantville•BradfordService Area: La Porte

Service Area: Northeast ButlerCambriaService Area: CoalportService Area: Nanty-GloFacility: Sci Cresson

•Cameron

Service Area: Snow ShoePopulation Group: Low Inc—Philipsburg

ChesterPopulation Group: Med Ind—Welsh Mountain

•ClarionService Area: Armstrong-Clarion

Shomper, Kris

Full Name: Melinda Jenkins, PhD, CRNPLast Name: Jenkins, PhD, CRNPFirst Name: MelindaJob Title: Asst. Prof, of Primary Care, Director-FNP ProgramCompany: University of Pennsylvania School of Nursing

Other Address: 420 Guardian DrivePhiladelphia, PA 19104-6096

Business: 215-898-2280Business Fax: 215-573-3781

E-mail: mjenkins@nursing.upenn.edu

07/10/2000 15:02 7172450953 MORGAN PLANT PAGE 82

;f ., Original: 2064 46

^ 1 REPRESENTATIVE VANCE: But you agreed to that

2 and you actually pushed that.

M 3 DR. McCORMICK: Well, what was the date?

4 REPRESENTATIVE VANCE: Early 90'$, It was

5 not that long ago, sir,

6 DR. McCORMICK; Well, the question I see

7 today is where do you set the standard of care for the

f a quality of care. Do you set it at the lowest possible

9 level or do you set it at the highest possible level?

10 You know, a lot of folks don't atop at stop signs.

11 Does that mean we should stop making that mandatory

12 that you stop at stop signs just because some people

13 don't do it?

14 REPRESENTATIVE VANCE: I'm not sure I follow

15 that correlation. We'll leave that issue alone. In

16 the interest of time, I will stop right now,

17 Mr. Chairman.

18 CHAIRMAN CIVERA: Representative Preston?

19 REPRESENTATIVE PRESTON: Thank you,

20 Mr. Chairman. When I was talking to Representative

21 Vance, it was the question about the physician's

22 assistant. Within my area, for example, I probably

23 have one of the few newer hospitals ever really close

24 in Allegheny County. That was the Forbes Hospital in

25 Wilkinsburg. The truth was, why it closed, the doctors

#

07/10/2000 15:02 7172450953 MORGAN PLANT

A47

1 didn't want to come in the area. That's why it closed

2 but yet in the sense they are more than happy to have

3 clinics there where they have physician assistants look

4 at someone but when the patient has to see the doctor,

5 they have to go all the way out to Monroeville.

6 Somewhere along the line we have to reach, coming into

7 the new millennium, a happy medium here and this kind

8 of looks like it because doctors don't make house calls

9 anymore. Nurse practitioners are in the area. This is

10 part of the issue that I'm dealing with because I have

11 — I don't know if it's still true or not but I used to

12 have the highest percentage of registered voters over

13 the age of 62 in the state as my constituents. I'm

14 concerned about that because I get more complaints

15 about the Access Program and things like that and I

16 have had it where I have other clinics in the area. I

17 have the Homewood area where doctors in Oakmont, the

18 patient is in Homewood and the patient calls me to ask

19 me, how am I getting advised on something because we

20 checked and the doctor wasn't even in the office in

21 Oakmont* I'm just giving you — these are some of the

22 examples of some of the problems and I would suggest to

23 you, ladies and gentlemen, that we have to come

24 together — 24, 25 years, eight years, you don't keep

25 your same computer or your same software. There is

07/18/2080 15:02 7172458953 MORGAN PLAN! rwot c.

1 going to have to be a little give and take and I think

2 that ia what the Chairman is saying and I understand

3 about the wall but I have been through — I have

4 supported you in a lot of cases but when L had the

5 podiatrist not being able to be a M.D. but an

6 ophthalmologist could be a M.D. I'm just looking at

i what I feel are very conservative opinions because you

8 want to hold on to your fort. Out of respect, we are

9 going to have to have a little give and take on this

10 position. I just wanted to bring this to your

11 attention, I'm more than happy to try to work with

12 you. Thank you, Mr. Chairman.

13 DR. McCORMICK: May I comment?

14 CHAIRMAN CIVERA: Yes, you may.

15 DR. McCORMICK: I think it boils down to the

16 same issue, number one. People should be doing the

17 things they are qualified to do and, number two,

18 because in some instances lower standards of care

19 exist, that doesn't mean it's correct and that we

20 should make that the common standard, I would submit

21 to you that what you are describing in your area is

22 ' inappropriate and that's not good medical care for the

23 patients of your district. I don't think lowering that

24 standard does anybody any good. ;

^ 25 REPRESENTATIVE PRESTON; But I think

07/19/2008 15:02 7172450953 MORGAN PLANT

!/

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49

1 somewhere along the line we have to have a good mixture

2 of quantity and quality and accessibility.

3 CHAIRMAN CIVERA: Representative Gordner?

4 REPRESENTATIVE GORDNER: Thank you,

5 Mr. Chairman, and thanks to Representative Dailey and

6 Representative Vance, my questions will be shorter than

7 yesterday. Dr. McCormick, you are actively involved in

8 family practice?

9 DR. McCORMICK; Yea.

10 REPRESENTATIVE GORDNER: How many docs are in

11 your practice?

12 DR. McCORMICK: There are six in our group.

13 REPRESENTATIVE GORDNER: Do you employ

14 physician assistants?

15 DR. MCCORMICK: No.

16 REPRESENTATIVE GORDNER: You have no

i? physician assistants?

18 DR. MCCORMICK: No.

19 REPRESENTATIVE GORDNER: Do you have any

20 nurse practitioners?

21 DR. McCORMICK: No.

22 REPRESENTATIVE GORDNER: If I could ask

23 Dr. Floyd the same thing. You are involved in OB-GYN?

24 DR. FLOYD: Currently,

25 REPRESENTATIVE GORDNER: And how many medical

07/10/2080 15:02 7172450953 MORGAN PLANT

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717-245 0953 (fax)

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Rural Route 5, Box 14632^0 !U! 13 Pi 9 : UO Honesdale, Pennsylvania 18431

July 10,2000

Robert Nyce, Executive Direct-Independent Regulatory ReviSW commission333 Market Street, Fourteenth FloorHarrisburg, Pennsylvania 17101

Original: 2064Dear Mr. Nyce,

I am a Family Nurse Practitioner residing and practicing in rural northeast PA. Iprovide Certified Registered Nurse Practitioner services in two healthcare offices inWayne County. My provision of professional services would be greatly impacted by theprescriptive authority regulations coming up for approval by the Independent ReviewCommission. At this time I urge you to disapprove the amendment to the CRNPregulations that were recently voted upon by the Board of Nursing. The issues I am mostconcerned about include:

1. The Two CRNP/1 Physician ratio. This ratio focuses on hypothetical andundocumented abuses of CRNP's by physicians, and is also incongruent withmost states, where such a ratio is not mandated (the two states that do havesuch a mandate require a 5 CRNP/2 physician ratio). The proposed ratiowould significantly limit the functioning of numerous CRNP practices, thuslimiting the provision of essential healthcare in and for underserved rural andrural populations.

2. The mandate of a specific 45-hour pharmacology course. Defining theadvanced pharmacology curriculum to include 45 hours in total, rather than45 hours in one course would allow credit for previous coursework, eventhough it may not have been all in one course. Such a provision would alsoallow for significant timesavings, when CRNPs could be serving patients.

3. Utilization of the American Hospital Formulary in the provision of drugcategories the CRNP is allowed to prescribe. The missing categoriesshould be inserted as drugs the CRNP may prescribe and dispense.

4. Authority over CRNP acts of medical prescription should be maintainedby the statutory Board authority, rather than by an individualcollaborating physician. CRNPs have been practicing collaboratively withphysicians for years, but the responsibility for a CRNP's prescriptiveresponsibilities should not rest with solely one physician.

Barbara Safreit, Associate Dean of Yale Law School, has written "Once the statehas legally recognized the Advanced Practice Nurse as a competent provider, it is oddindeed to condition practice upon the agreement or permission of a privateindividual... any state that adopts such a mechanism has in effect yielded itsgovernmental power to one individual...the physician" (Safreit, B.J,, 1996).

Owing to these factors, I respectfully request that you disapprove the regulationsand return them to the Board of Nursing. It is essential for the Board to represent theinterests of our profession.

Thank your for your consideration.

Sincerely yours,

Elizabeth A. Dom, M.S.N.,C.R.N.P.

EMBARGOED MATERIAL

2 IKaittflcB ILsim©s

July 8,2000 =; '-I ^

Mr. Robert Nyce, Executive Director O r i g l n a l : 2 0 6 4 I Z 2Independent Regulatory Review Commission i — • i333 Market St., 14th Floor % 9? gHarrisburg, PA 17101 - o o

Dear Mr. Nyce - ^

I am writing in regards to the proposed rules and regulations for certified registered nursepractitioners that were recently passed by the Boards of Medicine and Nursing, and will beup for review by you shortly. I am concerned specifically about two of the proposedregulations, one dealing with the requirement for a specific 45-hour pharmacology course,and the other for limiting the CRNP to physician ratio to 2:1, neither of which werementioned when the regs were published in the Pennsylvania Bulletin last fall.

The majority of us who received our master's degrees 8 or more years ago hadpharmacology integrated into our clinical and didactic courses and did not have a specificpharmacology course. This would require literally several thousand of us who now writeprescriptions with a physician's co-signature in the state (and have had no problems) to goback to school and take that course. It is like telling physicians who had only one year ofresidency many years ago and who have been practicing for years that, sorry, that's notgood enough - you have to go back for the additional two years of residency in order topractice, like everyone is now required to do. I feel that this would place an unnecessaryfinancial burden, in addition to the tremendous amount of time, on someone who, accordingto state laws, was adequately educated and has been practicing up to this time. I suggestthat, if this must stay in, you rephrase it to say a 45-hour course, "or its equivalent"

The second concern is that of the CRNP:physician ratio of 2:1. This is a totally arbitrarynumber, and no one on the Board of Medicine can come up with a reason as to why thiswas decided on. There are only two other states in the country who even have ratios, andthose are listed as 5:1. Many Nurse Practitioners practice part-time, and the physicians whoemploy them will be unduly restricted with this 2:1 clause. I suggest that you increase theratio to 5:1, and define the numbers as being full-time equivali

I am glad that we have at least come this far is granting prescriptive authority to NursePractitioners in Pennsylvania. I hope that you can view our suggestions with objectivity, anddo what is best for the health and welfare of the citizens of the Commonwealth.

Thank you for your time in this matter.

Sincerely,

Sharon L. Zache, RN, 1VIS, CRNP

Original: 2064

2000 JUL i3 AM G 52 E M B A R G O E D MATERIAL

^ 1003 North 64th StreetPhiladelphia Pa. 19151July 8, 2000

Mr. Robert NyceExecutive DirectorIRRC333 Market Street, 14th FloorHarrisburg, PA 17101

Dear Mr. Nyce:

As you review the new regulations for the practice of Certified Registered NursePractitioners in the state of Pennsylvania, I ask that you carefully consider the impact thatthese new regulations will have on the populations served by the nurse practitioners in thestate of Pennsylvania. While granting prescriptive authority to nurse practitioners willgreatly enhance the public's access to needed medications, there are numerouscomponents to the regulations as written that will negatively impact the ability of thenurse practitioners to provide care.

The first of these is the ration of 2 C R N P s to one physician. Currently I practice in anurse-managed center in a housing project in North Philadelphia. Seven part-time nursepractitioners collaborate with one family physician in providing excellent care. One ofthe main reasons that there are seven of us is that it is largely a faculty practice and eachnurse practitioner has faculty responsibilities and practices clinically part time. The 2:1ratio would virtually eliminate this style of practice at a loss both to the public who arereceiving care by a topnotch, well educated and current practitioner as well as to thefuture nurse practitioners who are being educated by someone who is currently clinicallyactive as well as academically sound. This ratio is completely arbitrary and has noprecedent in medical coverage. An attending physician on staff at a hospital is frequentlyresponsible for 8 or more residents, fellows and medical students at any given time.These are all considered training positions, as opposed to nurse practitioners that arealready fully licensed and able to provide safe and competent care I request that there beno such ratio

In addition, the regulations as currently written left out numerous categories that nursepractitioners routinely use to treat patients. These are eye, ear, nose, and throatpreparations, hormones and synthetic substitutes, oxytocics, unclassified therapeutic

agents, medical devices, and pharmaceutical aids. Following the language of theAmerican Hospital Formulary would maintain the current availability of medications.

Lastly, the new language reads that the collaborating physician can attest that "he or shehas knowledge or experience with any drug that a CRNP can prescribe." This holds thephysician liable for drugs used in an area in which the C R N P may have experience andcomfort in prescribing, but the collaborating physician does not use on a routine basis.One example of this may be a family practice physician who does not see childrenroutinely collaborating with a pediatric nurse practitioner who is well versed in the latestpediatric preparations. This limits the availability of the medications available tochildren due to a physician's inability to remain current in all medications in all fields.Given our pharmacology requirements, nurse practitioners would like to maintainresponsibility for those medications that we prescribe as opposed to placing theresponsibility on the physician.

Although these regulations were approved by our Board of Nursing under pressure fromthe governor, as a rule the majority of Nurse Practitioners in the state feel that althoughgranting us prescriptive authority, they place other restrictions which are unnecessary,were never open to public comment, and would limit the effectiveness of nursepractitioners and therefore impact negatively on the health of the citizens ofPennsylvania. We ask that they be returned to the Board of Medicine and Board ofNursing for further discussion.

Thank you for your time and attention to these matters. I can be contacted at 215-878-2993 for further discussion.

Sincerely,

PattyHewson, C R N P

Cc: Mario CiveraClarence Bell

Original: 2064

July 6, 2000 2 C Q f l J U L [ f ftH g . o o

"" REVIEW CO;,riiSSiON

§

Mr. Robert NyceExecutive Director IRRC333 Market St.14th FloorHarrisburg, PA 17101

Dear Mr. Nyce,

I am the President of the Nurse Practitioner Association of Southwestern Pennsylvania (NPASP)for the upcoming year. The group has been following the activity of the regulations onprescriptive privileges for nurse practitioners in PA. I heard today that the IndependentRegulatory Review Commission (IRRC) will be meeting to address this issue next week.

I am writing to request a report of the actions taken by the IRRC at that time and to find out whathappens after that. This will allow us to communicate with the nurse practitioners in our areaabout the status of this practice issue.

Thank you for considering this request.

Sincerely yours,

Linda Snyder, CRNPPresident - NPASP1528 Village Green DriveJefferson Hills, PA 15025(412)653-1237

Allyson P. Whittington BSN, MSN, PNP110 Whitney Drive 2008 JUL - 6 AM 8: 32Cranberry Twp, PA 16066

REVIEW COMMISSION

July 2, 2000

Mr Robert NyceExecutive Director, IRRC333 Market Street, 14th FloorHarrisburg, PA 17101

Dear Mr Nyce,

I am a Pediatric Nurse Practitioner (PNP) in the state of Pennsylvania, and I have reviewedthe amendment to the certified registered nurse practitioner (CRNP) regulations that wererecently approved by the Board of Nursing and Board of Medicine. I am aware of the vastamount of attention and effort on the Board's part that went into the negotiation of theamendment. However, I have grave concerns about the effects that these regulations may have onaccess to essential health care for children of the Commonwealth. I strongly urge the IRRC todisapprove the regulations based on the following four issues that are critical to the health, safety,and welfare of the citizens of the Commonwealth:

1. Ensure access to care by eliminating the 2 CRNP: 1 physician ratio.The ratio limitation is a substantive change that was added after the close of the October

1999 public comment period on the proposed regulations. Stakeholders and the public have hadno opportunity to comment on this most limiting and arbitrary aspect of the regulations. Whenobjections to the ratio were raised on 3/15/00 by members of the Board of Nursing and the Boardof Medicine, comments by the Chair of the Board of Medicine and the Physician General thatsupported the ratio focused on hypothetical and undocumented abuses of CRNPs by physicians.There are only two other states known to have ratios—New York and Colorado. The ratio in bothis 5 NPs: 1 physician. Access to care is clearly threatened by this tiny ratio, by the fact that aphysician-not a CRNP-must apply for the waiver, by the lack of definition of "good cause" for awaiver, and by the undefined process to obtain a waiver from the ratio. This contradicts theBoards1 claim in the Regulatory Analysis Form that "this rulemaking is expected to result ingreater availability of quality, cost-effective health care services". We believe that the ratio isindefensible and should be totally eliminated. CRNP practices and nurse-run centers across thestate provide essential health care for underserved rural and urban populations. Many of thesepractices can be recognized by their Medicaid, Title X, and CHIP reimbursement as well as bytheir large volume of uncompensated care. Most of these centers are staffed with multiple part-time CRNPs, are affiliated with schools of nursing, hospitals, and other reputable agencies, andhold numerous collaborative relationships. Unbiased research has shown their patient outcomes tobe equal to or better than those of physician practices. Prescribing CRNPs should not be forced topay the expense of a totally arbitrary number of physician collaborators. Prescribing CRNPsshould not be at the mercy of physician-initiated waivers to be determined by Boards with ahistory of over 20 years of stalemate regarding CRNP practice.

2. Allow summation of advanced pharmacology hours.Allow summation of advanced pharmacology hours to credit a total of 45 hours. A 45-

hour course was not specified in the proposed regulations published for public comment, nor inthe written comments of the Independent Regulatory Review Commission, nor in the writtencomments of the Pennsylvania Medical Society. While we acknowledge the importance ofadvanced pharmacology education for CRNPs, we believe that requiring "a specific course... ofnot less than 45 hours" is quite arbitrary. For the approximately 2,500 experienced PennsylvaniaCRNPs without a documented 45-hour course, the estimated cost of a 45-hour pharmacologycourse, including time lost from work, is $5,000.00, a substantial amount. Defining the advancedpharmacology hours to include 45 hours in total rather than 45 hours in one course would allowthem credit for previous coursework even though it may not have been all in one course. This willminimize costly tuition and time lost from work for CRNPs who have been safely practicing for

3. Follow the language of the American Hospital Formulary.Follow the language of the American Hospital Formulary cited to list each and every drug

category in the book. The missing categories must be inserted as drugs a CRNP may prescribeand dispense. These categories were discussed in the March 15 joint public meeting of the Boardsand their inclusion was a condition of the Board of Nursing's March 30 vote to approvethe regulations. They are: "eye, ear, nose, and throat preparations; hormones and syntheticsubstitutes; oxytocics; unclassified therapeutic agents; medical devices; pharmaceutical aids".

4. Maintain the statutory Board authority over CRNP acts of medical prescription insteadof shifting to an individual collaborating physician the authorization to identify drugcategories that a CRNP may prescribe and dispense.

Maintain the statutory Board authority over CRNP acts of medical prescription instead ofshifting to an individual collaborating physician the authorization to identify drug categories that aCRNP may prescribe and dispense. As published in October, the regulations listed only 5 classesof drugs that a CRNP might prescribe with authorization documented in the collaborativeagreement; 17 classes were allowed to be prescribed "without limitation". A substantive changewas made in the March 15 document to list 21 classes of drugs that must be authorized by thecollaborative agreement. Furthermore, the revised regulations require the collaborating physicianto attest "that he or she has knowledge and experience with any drug that the CRNP willprescribe." Thus, the revised regulations pin the responsibility and potentially very costly liabilityfor each and every prescription upon the collaborating physician. Again, the affected regulatedcommunity and the public have not had the opportunity to comment on this substantive change.

I agree with Barbara Safreit, Associate Dean of Yale Law School, who wrote, "Once thestate has legally recognized the APN [Advanced Practice Nurse] as a competent provider, it isodd indeed to condition practice upon the agreement or permission of a private individual... Anystate that adopts such a mechanism has in effect yielded its governmental power to one privateindividual, the physician... At worst, [such schemes] constitute a wholesale privatization of a coregovernmental function: assessing competence for licensed practice." (p. 452) [Safreit, B J (1992)

Health care dollars and regulatory sense: The role of advanced practice nursing. Yale Journal onRegulation, 9, 417-490.]

Please disapprove these regulations as written and return them to the Board of Nursing andthe Board of medicine for further negotiation. Thank you for your attention to these concernsbefore the regulations are approved.

Very truly yoursVery truly yours, * y

All/on P. Whittington V

I R R C # 2 0 6 4 F F T i t le Certified Registered Nurse Practitioner's Regulation(Form C - CRNPConcerns)

NAME ADDRESS DATE ofCORRESPONDENCE

Laura KindMcKenna, MSN,CRNP

7707 Pine RoadWyndmoor, PA 19038

June 7, 2000

Melinda Jenkins,PhD, CRNPDuplicate to Rep.Gannon

PO Box 360Swarthmore, PA 19081

June 7, 2000

Ann Lee, CRNP 116 Interstate PkwyBradford, PA 16701

June 8,2000

AnnLinguiti,MSN,RN,CRNP

7930 Montgomery Ave.ElkinsParlcPA 19027

June 7, 2000

Francine LoretoRedman, MSN,

142 South 2nd St.Columbia, PA 17512

June 11, 2000

James D. Mendez,MSN, CRNP

University of PA Medical CenterOne Silverstein3400 Spruce StreetPhiladelphia, PA 19104

June 7,2000

R. Alex Price, MSN,CRNP,CS

University of PA Health SystemGround Rhoads36th and Hamilton WalkPhiladelphia, PA 19104

June 12, 2000

Susan E. Potts-NultyMSN, CRNP

8056 Crispin St.Philadelphia, PA 19136

June 15, 2000

Nora MaGinnis,CRNP

No address given June 8, 2000

Elizbeth A. Coyne,RN, MSN, CRNP,CEN

7925 Ridge Ave. Unit #5Phildelphia, PA 19128

June 9, 2000

Alyson P.Whittington

110 Whitney DriveCranberry Twp., PA 16066

July 2, 2000

Ann Linguiti Pron,MSN, RN, CRNP

7930 Montgomery AvenueElkins Park, PA 19027

June 29, 2000

MiheeKim 1146 Harrogate WayAmbler, PA 19002

June 29, 2000

Sylvia Metzler 2232 N. Palethorp StreetPhila., PA 19133

June 29, 2000

Cynthia Krapels 501 S. Hancock StreetPhila., PA 19147

June 29, 2000

Jean Betschart MSN,MN, CPNP, CDEJeanne Smucker,CRNP,PhDAllyson PWhittingtonDenise Kochanek

Judity Worrell

Janet E Roach

Fran Cornelius

Maureen E. Leonardo

Margarete Lieb ZalonAllyson WhittingtonJennifer GabanyJo Ann D' Agostino

Donna L Torrisi

Karen Vujevich

Kathleen PalomboSorkinNancy Youngblood

Pamela Heald

Cynthia Gifford-HollingsworthJennifer Steele

3000 Swallow Hill Rd. # 517Pittsburgh, PA 152201054 Blackforest Rd.Pittsburgh, PA 15235110 Whitney DriveCranberry Twp., PA 16066114 Altadena DrivePittsburgh, PA 15228C/O Gwynedd-Mercy CollegeGwynedd-Valley, PA 194372221 North Broad StreetPhiladelphia, PA 19132854 Neighbor's WayPerkasie, PA 18944620 College HallPittsburgh, PA 15282Zalonml@UofS.edurswnapw@fyi.netJgabany@hotmail.com34* Street and Civic Center BoulevardPhiladelphia, PA 19104-43993205 Defense TerracePhiladelphia, PA 19129373 Burrows StreetPittsburgh, PA 15213-2261427 Greenhurst DrivePittsburgh. PA 15243153 Grandview RoadArdmore, PA 190031400 Locust StreetPittsburgh, PA 152193200 Henry AvenuePhiladelphia, PA 19129-11912209 Menlo AvenueGlenside, PA 19038

June 30, 2000

June 30, 2000

July 2, 2000

July 2,2000

June 29, 2000

June 29, 2000

June 27, 2000

July 2, 2000

July 6, 2000July 2, 2000July 8, 2000July 5, 2000

June 23, 2000

June 29, 2000

July 6, 2000

June 29, 2000

July 5, 2000

June 30, 2000

June 29, 2000

87/06/2000 11:43 2029662856

Pennsylvania Coalition of Nurse Practitioners893 Stone Jug Road, BiqlerviHe, PA 17307

BertsCounty NPs

Bucks/MontCounties NPs

PennsylvaniaNP Association

ChesJMontNP-PA Group

DelVal

Lehigh ValleyNP Group

Mid StateNP Association.

NortheastPennsylvaniaCoalition of

Care NPs

Original: 2064July 5,2000

PennsylvaniaNP Association

NPs ofSou* CentralPennsylvania

NP Associationof SouthwestPennsylvania

PhbddpNa

Association.

Tliree RiversChapter ofNAPNAP

Honorable John R. McGMey, Jr., ChairmanIndependent Regulatory Review Commission14* Floor, Harristown #2333 Market StreetHarrisbui&PA 17101

Re: 16A-499, State Boante of Medicine and Nursing

For the reasons set forth below, the Pennsylvania Coalition of Nurse Practitioners("PCNP") urges the Independent Regulatory Review Commission (TRRC) todisapprove final form regulations jointly submitted by the State Board of Medicine("Medical Board") and the State Board of Nursing ("Nursing Board") to establishparameters governing the prescribing and dispensing of drugs by CertifiedRegistered Nurse Practitioners ("CRNPs")*

The boards have "found" that the additions and changes in final form "do notenlarge the purpose of the proposed ndemaking." (Preamble 16A-499, p. 16)However, that finding is simplyoot conect

The PCNP would have preferred a different resolution by the Medical andNursing Boards on many substantive provisions of these regulations Nevertheless,the PCNP is basing its request for disapproval on only those provisions whichappeared in the regulations for the first time in foal form or which were changed inan especially egregious way in final form.

If IRRC were to disapprove these regulations and the Medical and NursingBoards were subsequently to amend the regulations to address the PCNP's objectionsadequately, the PCNP would not oppose the revised regulations when rcsubmittcdpursuant to 71 P. S. § 745.7(c).

Limitation on number of CRNP& per collaborating physician

Sections 18.57 and 21.287, would prohibit a physician from collaborating duringthe same time period with more than two CRNPs who prescribe and dispense drugs.A physician could ask the boards for a waiver of this limitation for "good cause,"For numerous reasons, these sections are the most objectionable provisions in theregulations.

87/06/2808 11:43 2829662856 PAGE 03

First, imposing a 2:1 ratio would disrupt the delivery of health care, especially in view of the feetthat physicians have frequently been collaborating with more than two CRNPs. The boards havecited no evidence to support the need for a 2:1 limitation. In feet, the two commentators whosecomments apparently served as the catalyst for these sections actually proposed a £ 1 ratio ratherthan the 2:1 ratio the boards adopted. (Preamble 16A-499, pp. 12-13)

Second, the proposed regulations contained no language imposing any limitation on the numberof prescribing CRNPs with whom a phyaciaa could collaborate. The insertion of the 2:1 limitationat the final form stage deprived both CRNPs and collaborating physicians of a fair opportunity tochallenge the limitation altogether or to present evidence supporting a ratio higher than 2:1.

Third, by articulating no standard other than "good cause," the boards have foiled to providenotice of the specific types of circumstances which would justify a "waiver" or to set forth thespecific criteria which the boards would use in evaluating waiver requests. For example, theregulations provide absolutely no indication if granting or denying waiver requests would dependsubstantially—or not at all—on the degree to which CRNPs are needed in a region because of theexistence of a physician shortage, on the relative education and experience levels of the specificphysician and CRNPs, on the nature of the practice involved, on the frequency with which thephysician would see the patient, on the range or type of drugs which the CRN? would prescribe anddispense, or on the number of non-prescribing CRNPs with whom the physician would also becollaborating. Because the regulations articulate no meaningful standards to guide the boards'decisionmaking, a physician would have no way to assess whether applying for a waiver would beworth the effort and to determine what evidence he or she would need to present Furthermore, thepotential for inconsistent and arbitrary decisions would be high.

Fourth, obtaining a waiver would require approval from both the Medical Board and the NursingBoard. It has taken those two boards 26 years to agree on regulations allowing CRNPs to prescribeand dispense drugs. In the absence of meaningful standards to guide their decisionmaking, there isno reason to believe that the boards would be able to agree on granting waivers in a timely manner.The feet that the boards have used the vague concept of "good cause" rather than meaningfulcriteria may well indicate that the boards are already having difficulty agreeing on the specificcircumstances under which waivers should be granted.

Fifth, the regulations fail to make clear if obtaining a waiver would mean that a physician couldcollaborate with an unlimited number of CRNPs or if the boards would apply different ratios on acase-by-case basis. If the former 6 the boards' intent, it is unlikely that many waivers would begranted. If the latter is the boards* intent, all of the aforementioned objections to the inadequacy ofthe "good cause" standard would apply as well to the failure to spell out the criteria for determiningwhat ratio should be set in particular waiver cases.

Initial education requirement

Sections 18.53(2) and 21.283(2) would require a CRNP who wishes to prescribe and dispensedrugs to complete a specific course in advanced pharmacology which is approved by both theMedical Board and the Nursing Board and which is not less than 45 hours m length. TheFCNFdidnot object to the provision in the proposed regulations requiring a prescribing CRNP to complete aCRNP program which "includes a core course in advanced pharmacology," nor do they object to

07/06/2800 11:43 2029662856 PAGE 04

being required to complete 45 hours of pharmacology preparation. The problem occurs when the45 hours is limited to a single course, since many NP programs provide combination of courses andintegrated content that exceed 45 hours, but do not have a specific course of 45 hours in thecurriculum. For instance, depending on the length of the semester or quarter, pharmacology coursescan be 30 hours in length with additional pharmacology content integrated into other courses. Thechanges the boards have made to the proposed regulations and the decision to make all provisionsof tt» regulatkms effective m ^ ^

First the failure to give credit for successfully completed pharmacology education, which wasnot part of a discrete course, would impose a time and financial hardship on many of the mostexperienced CRNPs, Although the PCNP believes the cost will actually be higher, the boardsthemselves have estimated the cost of the required 45 hours of education to be $630 to $1,875.(Regulatory Analysis Form, #3)

Second, the regulations do not themselves approve any specific providers or courses and do notspell out a procedure for either providers or CRNPs to apply for approval The regulations alsocontain no deadline for tfc boards to provide guidance to providers and CRNPs about whichcourses would qualify a CRNP to exercise prescribing authority. Therefore, it is entirely possiblethat no CRNP would be able to take advantage of the prescribing authority within the reasonablyforeseeable future.

Third, current regulations at 49 Pa. Code §§ 18.21-18.22 and 21,251-21.252 permit a CRNP tocollaborate with a physician regarding the prescription of drugs with the physician responsible forsigning the prescriptions. Nothing in the new regulations would expressly repeal §§ 18*21-18.22and 21.2S1~21.252. Furthermore, the boards have represented that the new regulations **wiH notaffect existing . . . regulations" of the Board of Nursing and the Board of Medicine, (RegulatoryAnalysis Form, #26) Therefore, it is assumed that a CRNP would have the option to continuefunctioning under the current regulations indefinitely or, at least, until the CRNP could successfullycomplete an approved 45-hour course. If that assumption is incorrect, then the Mure to delay theeffective date of the 45-hour requirement and the failure to provide guidance about approvedcourses would also create problems for CRNPs.

For all of the above reasons, the requirement of a single 45-hour course would causeextreme hardship for CRNPs and would disrupt the delivery of health care throughout theCommonwealth.

Continuing education requirement

Sections 18,53(3) and 21383(3) would require a prescribing CRNP to obtain 16 hours ofcontinuing education in pharmacology every two years. Although the PCNP supports continuingeducation for prescribing CRNPs, there axe serious problems with the regulations.

First, a CRNP would receive credit for only continuing education approved by the NursingBoard However, the regulations do not themselves approve any specific providers or courses, donot spell out a procedure for either providers or CKNPs to apply for board approval, and set notimetable for the Nursing Board to act.

07/06/2088 11:43 2829662855 PAGE 85

Second, because the regulations would take effect upon publication in the ;

(Regulatory Analysis Form, #30) and because the regulations provide no guidance to the contrary,the cotitimiing education requirement presumably would take effect with the next certificationrenewal date, Therefore, within a relatively short time period, a prescribing CRNP could berequired to complete a 45-hour course in phannacobgy in order to obtain prescribing authority ptus16 hours of continuing education. Although the PCNP believes the costs win be higher, the boardsthemselves have estimated the cost of the 45-hour course at $630 to $1,875 and the cost of thecontinuing education at $120 to $960. (ReguktoiyAiiatysisFonn, #17) Based on the boards1 OWBestimates, a CRNP could be forced within a relatively short period of time to spend as much as $750to $2,835.

Third, the proposed regulations contained no continuing education requirement.

Fourth, although the PCNP does not raise the point as an objection, it does wish to call toIRRC's attention that, historically, continuing education requirements have been imposed either bya statute setting forth the hours and parameters of the continuing education or by a statuteauthorizing or requiring a board or commWon to promulgate a continuing education requirementby regulation. There is no express authorization or requirement for continuing education forprescribing CRNPs in either the Professional Nursing Law or in the Medical Practice Act Theboards concluded that they have the legal authority for the requirement because of language in thecurrent regulations at 49 Pa, Code §§ I8.4l(c) and 21.271(d) requiring a CRNP to provide4<[e]videnee of continuing competency in the area of medical diagnosis and therapeutics/' If theboards are correct, then that language would also presumably authorize them to impose a continuingeducation requirement on non-prescribing CRNPs. Furthermore, approval of the continuingeducation requii^ment in the absence of clear statutory authorization would set a precedent for otherlicensing boards to establish continuing education requirements without statutory authorization.

Collaborative agreements

Section l&55(a) sad 2L285(a) are, in eflfect, definitions of "collaborative agreement." SectionsI8.55(b) and (c) and 2L285(b) and (c) would apply expressly to collaborative agreements betweena prescribing CRNP and the collaborating physician. However, the boards have stated that theregulations "define and require a written collaborative agreement" and that "Jajfl [of the 4.667registered] CRNPs will be expected to conply with the requirement of a written collaborativeagreement." (emphasis added) (Regulatory Analysis Foxra, #8 and #15, respectively) As interpretedby the boards, there are serious problems with the purported "requirement" for a writtencollaborative agreement for CRNPs who do not wish to prescribe and dispense drugs.

First, the proposed regulations contained no language regarding collaborative agreementsbetween a non-prescribing CRNP and the physician. Therefore, the insertion of a "requirement" inthe final form regulations applicable to non-prescribing CRNPs deprived both noivprescribingCRNPs and their collaborating physicians of notice and an opportunity to be heard on a matterwhich could have a serious effect on them.

Second, notwithstanding the boards' representations in the regulatory analysis, the actuallanguage of Sections 18.55(a) and 2JT285(a) does not expressly require non-prescribing CRNPs tohave a written collaborative agreement. To the contrary, a feir reading leads to the conclusion that

07/06/2000 11:43 2029662856 PAGE 06

Sections 18.55(a) and 21.285(a) simply define the term "collaborative agreement" for proposes ofSections 18.55(b) and (c) and 21.28S(b) and (c).

Third, the current regukdons at 49 Pa. Code §§ 18.21 and 21.251 require that CRNPs performcertain functions in "collaboration with" a physician but do not require a written collaborativeagreement between a specific GKNP and a specific physician. Especially in an institutional setting,it is common for a CRNP to have a collaborative agreement which, in effect, covers the CKNP anda number of physicians. Requiring a written collaborative agreement between a CRNP and eachphysician on the immediate effective date of the new regulations would disrupt the delivery ofhealth care across the Commonwealth.

Fourth* the boards have cited no evidence of the need to impose Sections 18.55 and 21.285 onnon-prescribing CRNPs. In feet, in explaining the genesis and rationale for these sections, theboards referred to commentators—including IRRC—which recommended written collaborativeagreements before the CRNP could preqmfce folgfl (Preamble 16A-499, pp. 6-7)

Identification of CRNFs

Sections 18.56 and 21.286 would require §fl CRNPs to disclose that they are CRNPs and to wearname tags identifying themselves as CRNPs. Purely from the standpoint of public policy, thesesections do not raise the same level of concern as do the provisions analyzed in the foregoingparagraphs. However, consistent with its comments on other parts of the regulations, the PCNPnotes several problems with these sections.

First, because the proposed regulations contained no language regarding disclosures and nametags and did not address practice by CRNPs who do not wish to prescribe and dispense drugs, non-prescribing CRNPs were deprived of notice and an opportunity to be heard on a matter affecting

Second, the boards represented that the disclosure and name tag requirements are a response torecommendations by several coimncntators—iicludmg IRRC—that "a CRNP who prescribes

ttons provide clear and conspicuous notice to patients that he or she is a CRNP." (emphasisadded) (Preamble 16A-499, p. 12) The boards cited no evidence of the need to impose theserequirements on non-prescribing CRNPs.

Thank you for your consideration.

^Sincerely,

JadTowers, PhD, NPC, CRNP (ENP)Chair PA Coalition of Nurse Practitioners

97/06/2880 11:43 2829662856

Pennsylvania Coalition of Nurse Practitioners893 Stone Jug Road, Biglerville, PA 17307 RFC-r.'FD

BerksCounty NPs

Buds/MontCounties NPs

PennsylvaniaNP Association

CheaJMontNP-PA Group

NAPNAP

Lehigh ValleyNP Group

MM StateNP Association.

NortheastPennsylvaniaCoalition of

NorthwesternPennsylvaniaNP Association

NPs ofSouth CentralPennsylvania

NP Associationof SouthwestPennsylvania

Philadelphia

Association.

Three RiversChapter ofNAPNAP

20D0 JUL-6 PM l« 18

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TELEPHONE NUMBER: 717-334-2462

FAX NUMBER: 717-334-4075

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Robert Nyce, Executive Director 2000 JUL - 6 AM 8: 36Independent Regulatory Review Commission333MaiketSt., 14*Floor '^REViav c o ^ s s l o ^ ^Harrisburg, PA 17101

Original: 2064Dear Mr. Nyce:

I am a Women's Health Nurse Practitioner residing in Northeast PA. I currently providepatient care in a Family Planning Center. I urge you to disapprove the amendment to theCRNP regulations that were recently voted upon by the Board of Nursing. I am mostconcerned about:1. The 2 CRNP / 1 physician ratio. This not only focuses on hypothetical and

undocumented abuses of CRNP's by physicians, but also is not congruent with moststates which do not have ratios (the two that do have a 5 NP: 2 physician ratio).Establishing a 2:1 ratio would limit/curtail the functioning of many CRNP practicesand nurse-run centers across the state which provide essential health care forunderserved rural and urban populations.

2. Requiring a specific 45 hour pharmacology course.Defining the advanced pharmacology hours to include 45 hours in total rather than 45hours in one course would allow credit for previous coursework even though it maynot have been all in one course.

3. Follow the language of the American Hospital Formulary cited to list each andevery drug category in the book The missing categories must be inserted as drugsa CRNP may prescribe and dispense.

4. Maintain the statutory Board authority over CRNP acts of medical prescriptioninstead of shifting to an individual collaborating physician the authorization toidentify drug categories that an ARNP may prescribe and dispense. Theserevisions place the responsibility and liability for each and every prescription uponthe collaborating physician.I agree with Barbara Safreit, Associate Dean of f Yale Law School:Once the state has legally recognized the APN (Advanced Practice Nurse) as a

competent provider, it is odd indeed to condition practice upon the agreement orpermission of a private individual... any state that adopts such a mechanism has in effectyielded its governmental power to one individual... the physician. (Safreit, B.J., 1996).

PLEASE ASK DISAPPROVE THE REGULATIONS AND RETURN THEM TOTHE BOARD OF NURSING. IT IS ESSENTIAL FOR THIS BOARD TOREPRESENT THE INTERESTS OF OUR PROFESSON.

Sincerely,

Sheela PorteirsmitSheela Port&smith CRNP

RECEIVEDHOUSE OF REPRESENTATIVES

COMMONWEALTH OF PENNSYLVANIA 2D0fl JAM I 8 AMI|:(*(*

* * * * * * * * * * * *

House B i l l 50

REVitW COMMISSION

House Professional Licensure Committee

Room 140Main Capitol BuildingHarrisburg, Pennsylvania

Thursday, October 28, 1999 - 9:34 a.m.

— o O o —

BEFORE:

Honorable Mario Civera, Majority ChairpersonHonorable Stephen BarrarHonorable Karl BoyesHonorable John LawlessHonorable Sandra MajorHonorable Jerry BailorHonorable Patricia VanceHonorable Kathy ManderinoHonorable Joseph Markosek

ORIGINAL: 2064HARBISONCOPIES:McGinleySandusky

VyatteNotebook

Original in

TROUTMAN REPORTING SERVICE(570) 622-6850

BEFORE:

HonorableHonorableHonorableHonorableHonorableHonorableHonorableHonorableHonorableHonorableHonorableHonorableHonorableHonorableHonorable

HOUSE OF REPRESENTATIVESCOMMONWEALTH OF PENNSYLVANIA

< * ^ * 4» J» • • ^ • • *

House Bill 50

• ^ » ^ ^ ^ • ^ 4> • •

RECEIVED2000 JAN 18 ftMIl- Ul«

*

House Professional Licensure Committee

Room 140Main Capitol BuildingHarrisburg, Pennsylvania

Wednesday, October 27, 1999 - 10:05 a.m.

-—oOo—-

Mario Civera, Majority ChairpersonStephen BarrarKarl BoyesMary Ann DaileyJulie HarhartSandra MajorJerry NailorRon RaymondPatricia VanceJohn GordnerWilliam KellerJoseph MarkosekDavid MayernikMichael McGeehanConnie Williams

ORIGINAL: 2064HARBISONCOPIES:

HcGinelySandusky

Notebook

TROUTMAM REPORTING SERVICE(570) 622-6850

FromState Representative MariO J. Civera, Jr.Pennsylvania House of Representatives

164th Legislative District

District Office:232 Long Lane

Upper Darby. PA 19082(610)352-7800

Capitol Office:Post Office Box 202020

House of RepresentativesMain Capitol Building

Hamsburg, PA 17120-2020(717)787-3850

Q^For Your Informationa As Per Your Request

\sgVv>\vA 2JTOO

MARIO J,CIVERA, JR., MEMBERHOUSE POST OFFICH BOX 202020

MAIN CAPITOL BUILDINGHARRISBURG, PENNSYLVANIA 17120-2020

232 LONG LANEUPPER DARBY, PENNSYLVANIA 19082

COMMITTEES

PROFESSIONAL LICENSURI-,MAJORITY CHAIRMAN

LIQUOR CONTROLFIREFIGHTERS' CAUCUS,

COCHAIRMAN EMERITUS

ORIGINAL:HARIBSONCOPIES: McGinley

Sandusky— •-/

Notebook (2)

tfousi of *RgpresentativesCOMMONWEALTH OF PENNSYLVANIA

HARRISBURG

November 16 ,1999

John R. McGinley, Jr., ChairmanIndependent Regulatory Review Commission14th Floor, Harr istown 2333 Market StreetHarr isburg, PA 17101

Dear Chai rman McGinley:

UK$

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1I

4?

Om•<o

This is to advise you that the House Professional Licensure Committee met onNovember 16, 1999, and submits the following comments pertaining to the regulationsconsidered by the Committee:

The Committee voted to take no formal action on Regulation 16A-499 until final-formregulations are promulgated. However, the Committee submits the following comments:

1. The Committee recommends that a minimum number of hours of coreeducation in advanced pharmacology be required In order for a CRNP to be permitted toprescribe and dispense drugs, and that a minimum number of hours of continuingeducation in advanced pharmacology be required per biennium in order for a CRNP tomaintain prescriptive authority.

2. The Committee recommends that a collaborative agreement between a CRNP and aphysician be in writing, that the agreement contain a list of the classes of medicationsthat the CRNP is authorized to prescribe, that the agreement identify the collaboratingphysician, and that the agreement provide for an identified substitute collaboratingphysician for up to thirty days when the collaborating physician is not available.

3. The Committee recommends that a CRNP who prescribes medicationsprovide a clear and conspicuous notice to patients that he or she is a CRNP.

The Committee voted to take no formal action on Regulation 16A-600 until final-formregulations are promulgated. However, the Committee submits the following comments:

1. The fee report forms list a total estimated cost for each service based on aformula of staff time expended plus average administrative overhead. However, in allcases the proposed fee to be charged is rounded up to the nearest five dollar increment.The Committee is requesting an explanation as to why the proposed fees are roundedup and are not the actual cost of services as estimated by the Board.

John R. McGintey. Jr., ChairmanIndependent Regulatory Review Commission

November 16,1999

2. Information regarding expenditure history has not been provided in Section 20b ofthe Regulatory Analysis Form as required. The Committee is requesting that the Boardsubmit the expenditure information, income figures and an explanation of theadministrative overhead costs contained in the fee package. The administrativeoverhead cost for certification of license history Is listed as $9.76, while all otherservices are listed as $11.53. The Committee is requesting an explanation as to whataccounts for the difference in administrative overhead costs.

The Committee voted to take no formal action on Regulation 16A-422 until final-formregulations are promulgated. However, the Committee submits the following comments:

1. The Committee is requesting additional information as to the category of"certification of ticensure, registration or scores." The Committee is questioning underwhat circumstances the Board would "certify" an examination score.

2. The fee report forms list a total estimated cost for each service based on aformula of staff time expended plus average administrative overhead. However, in allcases the proposed fee to be charged is rounded up to the nearest five dollar increment.The Committee is requesting an explanation as to why the proposed fees are roundedup and are not the actual cost of services as estimated by the Board.

3. The administrative overhead costs for certification of examination scores is listed as$9.76 while all other services are listed as $8.08. The Committee is requesting anexplanation as to what accounts for the difference in administrative overhead costs.

4. The Committee notes that the expenditure history information provided inSection 20b of the Regulatory Analysis Form shows a substantial Increase from 1996-97to 1997 98 (from $305,331 to $347,362). Expenditures for 1998-99 are budgeted at$345,000. The Committee is requesting an explanation as to what accounted for theincrease, including an itemized list of income and expenditures for the fiscal years listedon the form. Without an understanding of the nature of the expenditures it is notpossible to assess what costs are reflected in the administrative overhead fees.

5. The Committee notes an apparent typographical error on the Fee Report Form forApplication for Licensure of Barber School, The proposed fee is listed as $335.00 at thetop of the form and $280.00 on the bottom. The $280.00 figure Is consistent with otherportions of the rulemaking package.

6. The Committee notes that the fee for Application for Licensure of Barber Schoolwouk) be increased significantly, and mat the bulk of the increase would be attributed toa cost of $195.50 for the Board to meet for a half hour and vote on the application. TheCommittee Is requesting an explanation as to why it would be necessary for the Boardto take a half hour of time in order to discuss and vote on an application.

John R. McGlnley, Jr., ChairmanIndependent Regulatory Review Commission

November 16,1999

The Committee voted to approve Regulation 16A-567.

Please feel free to contact my office if any questions should arise.

Sincerely,

*~7rjaA*Mario J. Cirera, ChairmanHouse Professional Licensure Committee

MJC/smsEnclosurescc: Daniel B. Kimball, Jr., M.D., Chairman

State Board of MedicineM. Christine Alichnie, Ph.D., RN, Chairperson

State Board of NursingRobert G. Pfckerill, ChairmanState Board of Vehicle Manufacturers,Dealers and Salespersons

Richard Sciorilfo, ChairmanState Board of Barber Examiners

Rita Halverson, ChairpersonState Real Estate Commission

Honorable Kim H. Pizzingrilll, Secretary of the CommonwealthDepartment of State

RECEIVEDORIGINAL: 2064Harbison 1999 KOV I 8 AH 10= 5«4C0PIES: S * i H D^sas^ia?R Y

Smith ^ 0W y a t t e ^ - ^ — + • - •-"•—

Notebook (2) Regulation 16A-499

State Board of Nursing and State Board of Medicine

PROPOSAL: Regulation 16A-499 amends 49 PA Code, Chapter 18, regulations of the StateBoard of Medicine, and Chapter 21, regulations of the State Board of Nursing. Section 15(b) ofthe Medical Practice Act of 1985, 63 P.S. Sec 422.15(b), authorizes the boards to promulgateregulations which would authorize Certified Registered Nurse Practitioners to prescribemedications. The proposal would add two new sections to existing regulations regardingCRNPs, who are jointly regulated by the two boards. The first section sets forth the minimumrequirements a CRNP must meet in order to prescribe and dispense drugs. The second sectionspecifies which drugs a CRNP may prescribe and dispense, drugs which may be prescribed withrestrictions, and drugs which may not be prescribed.

The proposed Rulemaking was published in the Pennsylvania Bulletin on October 2,1999. TheProfessional Licensure Committee has until November 22, 1999, to submit comments on theregulation.

ANALYSIS: Proposed Sections 18.53 and 21.283 provide that a CRNP may prescribe anddispense drugs if the CRNP has completed a CRNP program which is approved by the Boards,and if the CRNP program includes a core course in advanced pharmacology. A prescribingCRNP would be required to comply with standards of the State Board of Medicine relating toprescribing, administering and dispensing controlled substances, and packaging and labeling ofdispensed drugs. A prescribing CRNP would also be required to comply with standards of theDepartment of Health relating to prescriptions and labeling of drugs, devices, cosmetics andcontrolled substances.

Pursuant to paragraph (a) of proposed Sections 18.54 and 21.284, the Boards would adopt theAmerican Hospital Formulary Service Pharmacologic-Therapeutic Classification to identifydrugs which a CRNP may prescribe and dispense, subject to other regulatory parameters.Paragraph (b) lists 17 classes of drugs which a CRNP may prescribe without limitation.Paragraph (c) lists five classes of drugs which a CRNP may prescribe if authorization isdocumented in the collaborative agreement with a physician. Paragraph (d) prohibits a CRNPfrom prescribing gold compounds, heavy metal antagonists and radioactive agents. The full listof these drugs is set forth in Annex A of the Boards' proposed rulemaking package.

Paragraph (e) of proposed Sections 18.54 and 21.284 provides that a collaborating physician wholearns that a CRNP is prescribing or dispensing inappropriately shall immediately advise theCRNP to stop prescribing and dispensing and the pharmacy to stop dispensing the drug. TheCRNP shall immediately advise the patient to stop taking the drug, and the action shall be notedby the CRNP in the patient's medical record.

Paragraph (f) would permit a CRNP to prescribe a Schedule II controlled substance for up to a 72hour dose. The CRNP would be required to notify the collaborating physician of the prescriptionwithin 24 hours. A CRNP would be permitted to prescribe a Schedule III or IV controlledsubstance for up to 30 days. The prescription would not be subject to refills unless authorized bythe collaborating physician. Paragraph (g) would prohibit a CRNP from prescribing a Schedule Icontrolled substance, from prescribing a drug for a use not permitted by the U.S. Food and DrugAdministration, and from delegating his or her prescriptive authority to another health careprovider.

Paragraph (h) would require that the name and certification number of the CRNP be in printedformat at the top of the prescription blank, and a space for the entry of the DBA registrationnumber, if appropriate. The collaborating physician would also be identified as required by-Medical Board regulation 16.91. Paragraph (i) would require that the CRNP to document in apatient's medical record the name, amount and dose of the drug prescribed, the number of refills,the date of the prescription and the CRNP s name.

RECOMMENDATIONS: It is recommended that the Professional Licensure Committee takeno formal action until final form regulations are promulgated. However, the committee offersthe following comments:

1) The Committee recommends that a minimum number of hours of core education in advancedpharmacology be required in order for a CRNP to be permitted to prescribe and dispensedrugs, and that a minimum number of hours of continuing education in advancedpharmacology be required per biennium in order for a CRNP to maintain prescriptiveauthority.

2) The Committee recommends that a collaborative agreement between a CRNP and a physicianbe in writing, that the agreement contain a list of the classes of medications that the CRNP isauthorized to prescribe, that the agreement identify the collaborating physician, and that theagreement provide for an identified substitute collaborating physician for up to thirty dayswhen the collaborating physician is not available.

3) The Committee recommends that a CRNP who prescribes medications provide a clear andconspicuous notice to patients that he or she is a CRNP.

House of RepresentativesProfessional Licensure CommitteeNovember 10, 1999

POMA

2000-2001 Officers

Suzanne K. Kelley, DO.President

Gary H Plundo, D.O.President-elect

Ernest R. Gelb, D O .Vke President

William A. Wewer, D.O.Secretary/Treasurer

John F. Callahan, D.O.Immediate Past President

TrusteesKenneth J. Veit, D.O.District One

Lenwood B. Wert, D.O.District Two

Robert P Oristaglio, Jr., D.O.District Three

William J. Kuprevich, Jr., D.O.District Four

William P. Brown, D.O.District Five

Domenick N. Ronco, D.O.District Six

Stephany F. Esper, D.O.District Seven

ITiomas R. DeGregory, D.O.District Eight

William R Henwood, D.O.District Nine

Jeffrey C. Brand, D.O.District Ten

Samuel J. Garloff, D.O.District Eleven

John L. Johnston, D.O.District Twelve

Jeflfry A. Lindcnbaum, D.O.District Fourteen

Trustees-at-LargeMichael F. Avallone, D.O.Philadelphia

Silvia M. Ferretti, D.O.

Leslie T. Pal)one, D.O.

Hugh E. Palmer, D.O.

Judith R. Pryblick, D.O.AUentoum

Earle Noble Wagner, D.O.Qteltenliam

George L. Weber, D.O.Philadelphia

Speaker of the HouseHymen KanofT, D.O.

Executive DirectorMario EJ . Lanni

717-939-9318In Pa. 1-800-544-POMA

Fax 717-939-7255e-mail poma@poma. org

; June 29,2000

Original: 2064

V, PENNSYLVANIA| OSTEOPATHICs'- MEDICAL

ASSOCIATION p r r 7 n / r: n

Commissioner John R. McGinley, Jr., ChairIndependent Regulatory Review Commission333 Market Street, 14th FloorHarrisburg, PA 17101

RE: Final Rulemaking : State Board of Osteopathic Medicine, State Board ofNursing CRNP Prescriptive Authority (16A-499)

Dear Commissioner:

The regulations have been forwarded to the Independent Regulatory ReviewCommission for final review.

The Pennsylvania Osteopathic Medical Association (POMA) wouldappreciate clarification as to how these regulations will affect the osteopathicphysicians entering into collaborative agreement.

The osteopathic physician is under the State Board of Osteopathic Medicine,however the CRNP is under the State Board of Nursing and the State Board ofMedicine.

We look forward to your response.

Sincerely,

Suzanne K. Kelley, D.O.President

SKK/dll

c: The Honorable Clarence Bell, Chair, Senate Consumer Protection andProfessional Licensure Committee

The Honorable Mario Civera, Chair, House Professional Licensure CommitteeCharles D. Hummer, M.D., Chair, State Board of MedicineDaniel D. Dowd, Jr., DO., Chair, State Board of Osteopathic MedicineRobert S. Muscalus, DO., Physician General

G:\DOCS\LEGISLAT\IRJlC-RE-CRW-JUNE-2000.wpd

1330 EISENHOWER BOULEVARD, HARRISBURG, PA 17111-2395

PENNSTATE p C C c .Mrn^ -->. I H tV-nn Slate Berks (610) 3%-60()()r>. I H l > c n n ^U l ! c ^ C l ^ s

^ i j jM^n H^ 5* ^ Tulpehockcn Road Websile: liltp://w\vvv.bk.psii.edui U U J U - i * > J " p.(). Box 7009

> % ' ' 'Reading. PA I%IU-N)(N

June 28, 2000

To: Robert Nyce, Executive Director

From: Cindy D Schmeltz MSN, CRNP, FNP-C

Re: Prescriptive Authority

Dear Mr. Nyce,

I would like to express my concerns regarding the prescriptive regulations that are currently being

considered. I would like to suggest an alternative to a credit pharmacology course. Many in

master programs had an advanced pharmacology course but it might have only been a 3 credit course, or

had the pharmacology incorporated within the clinical components which would not meet your proposed

criteria. Additionally, most practicing nurse practitioners have attended nationally recognized conferences

for continuing education and may have accumulated additional credits / ceu s in this area. Since our

surrounding states do not have such stringent criteria, could Pennsylvania model our neighboring states

which has proven to be a safe and acceptable practice? Must the criteria be based on a course we might

have had several years ago? Could continuing education and current clinical practice be included in this

criteria. It is in this method that we remain clinically current-not from the ancient pharmacology course but

in day to day practice and continuing education.

I would also like to address the issue of the nurse practitioner / physician ratio of 2:1.1 believe that

this might cause a significant hardship on certain practices. Most states have a 5:1 ratio, which seems to be

more reasonable. Some practices hire multiple practitioners, supplement with part time staff or a physician

might serve as a collaborating physician for multiple sites. For example; in my situation in college health.

My collaborating physician oversees our health center, and two other colleges. He also has NP's in his

private office practice in 2 locations. So which one of us does he tell he can no longer work with? Do you

honestly believe that there are enough physicians who are supportive of NP practice to support the 2:1

ratio? I believe that we are lucky to find a physician to be supportive in collaboration at all in the state of

Pa. Is there a logical and reasonable explanation why these criteria are being considered? Or is it just that

the physicians have a stronger, more influent and powerful lobbying body? I ask you to honestly and

logistically consider ... does this make sense?

Sincerely,

Nurse Practitioner-Supervaa&rHealth Services

The Berks-Lehigh Valley College An liqual Opportunity University

Gelnett, Wanda B.

From: Jenkins, Melinda [mjenkins@nursing.upenn.edu]Sent: Thursday, June 29,2000 2:54 PMTo: 1nrc@irrc.state.pa.us'Cc: 'Mrgnplant@aol.com1; Jenkins, MelindaSubject: CRNP regs amendment

Original: 2064

In response to some questions raised by Mr. John Jewett, I havediscovered 2web sites that may assist the IRRC in thinking about the differencebetweenPhysician's Assistant education and practice and CRNP education andpractice.

http://www.aapa.org/ is the web site of the national organization thatacredits PA educational programs.

Go to PA Prof & Educ, then PA Educ, then Standards, then Section II

general information on curriculum. There is another page that lists PAprograms in Pennsylvania. It is evident from the information given thatthere are a variety of levels of education for PAs. Some programs give

certificate, some a bachelor's degree, and some a master's degree. It

most likely that programs that do not give a master's degree do notincludea course that could be described as "advanced pharmacology" at thegraduate

http://www.pacode.com/secure/data/049/chapterl8/subchapDtoc.html is

web site that lists the Pennsylvania rules and regs for Physician'sAssistants. It is not possible to tell from the regs exactly what isrequired as far as "advanced pharmacology". It is stated thatPennsylvaniaprograms must meet the national standards that are described above.

From what I can see, there is no written requirement for PAs inPennsylvaniato have a course in "advanced pharmacology" of any length. Neither is

any licensure of PAs in Pennsylvania, nor in most other states. Theypractice under the physician collaborator's license. However, CRNPs arelicensed/certified independently in almost every state. This is the

difference between CRNPs and PAs nationwide. CRNPs and PAs are notequivalent under the law.

The book by Carolyn Buppert, previously given to Mr. Jewett, contains

regulations from all states in the U.S.

Please contact me if you would like further information.

Melinda Jenkins, PhD, RN,CSAssistant Professor of Primary CareDirector, Family Nurse Practitioner ProgramUniv. of Pennsylvania School of Nursing

420 Guardian DrivePhiladelphia, PA 19104-6096215-898-2280, fax 215-573-7381